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Predictors of obturator functioning and satisfaction in Turkish patients using an obturator prosthesis after maxillectomy
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Predictors of obturator functioning and satisfaction in Turkish patients using an obturator prosthesis after maxillectomy Meltem Ozdemir-Karatas, PhD, DDS,a Ali Balik, PhD, DDS,a Gülümser Evlioglu, PhD, DDS,a Ömer Uysal, PhD,b and Kadriye Peker, PhDc Objective. The aim of this study was to determine the sociodemographic, behavioral, and clinical factors affecting obturator function and satisfaction using the obturator functioning scale (OFS) in maxillectomy patients rehabilitated with obturator prostheses. Study Design. The study sample consisted of 41 maxillectomy patients. The OFS was translated into Turkish and adapted for assessing obturator functioning and patient satisfaction among Turkish patients. Data were collected from patients’ medical records and self-completed questionnaires, including the Turkish version of the OFS, sociodemographic and behavioral characteristics. Descriptive statistics, Mann-Whitney U test, Spearman’s correlation coefficient, and backward stepwise multiple linear regression were used for data analysis. Results. Internal consistency (Cronbach’s alpha = 0.85) and test–retest reliability (intraclass correlation coefficient = 0.86) were acceptable for the OFS. The most frequently reported problem was “difficulty chewing.” Bivariate analysis revealed significant differences in total OFS scores in terms of surgery type, defect size, and education level, except for the other clinical and sociodemographic characteristics and behavioral factors. Education level and surgery type were found to be the most important predictors of patient satisfaction and functioning of the obturator. Conclusions. The Turkish version of the OFS might be a useful tool for clinicians to identify patients who are at risk for poor functioning of the obturator, lack of satisfaction, and unmet needs. (Oral Surg Oral Med Oral Pathol Oral Radiol 2017;■■:■■–■■)
In recent years, health-related quality of life (HRQOL) and treatment satisfaction have been progressively acknowledged as patient-reported outcome measures in the prosthetic rehabilitation of patients with head and neck cancer.1,2 After resection of maxillofacial tumors, patients have to deal with orofacial functional problems and emotional issues that might have significant negative effects on the HRQOL of patients and their caregivers. In the management of maxillary defects, obturator prosthesis is the most widely used noninvasive approach to restore the patient’s oral functions, aesthetics, and resocialization.3-5 There are several studies examining patients’ HRQOL and its relationship to obturator functioning.4-11 However, to our knowledge, there are no published studies evaluating the functioning of the obturator and the satisfaction of Turkish patients with obturator prostheses after total maxillectomy. In previous studies, generic HRQOL measures were commonly used in combination with HRQOL measures for head and neck cancer, and HRQOL measures specific for oral health were used for assessing the treatment outcomes of oral rehabilitation. A recent consensus report on orofacial rehabilitation12 and a structured
review of studies reporting specific functions in patients with head and neck cancer states that more sensitive and specific measures are needed for assessing the impacts of oral rehabilitation on patients’ HRQOL because the existing measures seem to lack the discriminating ability to measure the effects of oral rehabilitation on HRQOL in these cases.13 Recognizing the importance of oronasal functions on HRQOL outcomes, the obturator functioning scale (OFS) was developed at the Memorial Sloan Kettering Cancer Center with the aim to assess the selfreported functioning of and satisfaction with the obturator prosthesis in maxillectomy patients.10 Besides clinical parameters, using this subsite and performance-based specific HRQOL measure may provide useful information about patients’ unmet needs and expectations, as well as the effectiveness of the prosthodontic treatment.13 Reconstruction with a prosthetic obturator is the most preferred method in Turkey. Our institutional experience has indicated that many patients are dissatisfied with their obturator prostheses and its poor functionality. It is known that evaluation of HRQOL and functional outcomes after prosthetic rehabilitation of patients with head and neck cancer is critical for optimal patient care and
a
Department of Prosthodontics, Faculty of Dentistry, Istanbul University, Capa, Istanbul, Turkey. b Department of Medical Statistics and Informatics, Medical School, Bezmialem Vakif University, Fatih, Istanbul, Turkey. c Department of Dental Public Health, Faculty of Dentistry, Istanbul University, Capa, Istanbul, Turkey. Received for publication Aug 10, 2017; returned for revision Oct 24, 2017; accepted for publication Nov 4, 2017. © 2017 Elsevier Inc. All rights reserved. 2212-4403/$ - see front matter https://doi.org/10.1016/j.oooo.2017.11.002
Statement of Clinical Relevance This study aimed to investigate the causes of problems with chewing and swallowing, food leakage, and speech problems in patients with head and neck cancer and to increase the quality of life of these patients by proposing solutions to these problems. 1
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comprehensive evaluation of treatment options.14 Thus, this pilot study aimed to determine the sociodemographic and clinical factors affecting functioning of and satisfaction with obturator prostheses using the OFS in Turkish patients rehabilitated with maxillary obturator prostheses after maxillectomy.
MATERIALS AND METHODS Forty-one patients who had undergone maxillectomy and been rehabilitated with obturator prostheses at the Prosthodontics Clinic of a dental teaching hospital in Istanbul, Turkey, were recruited to participate in this crosssectional study. Patients were selected consecutively during their annual checkup visits to our hospital between January 4 and April 30, 2014. The inclusion criteria for maxillectomy patients were (1) age 18 years or over; (2) use of a definite obturator prosthesis for at least 6 months; (3) having a clinically and functionally acceptable prosthesis, according to the criteria defined by Beumer et al.,15 including consideration of efficiency of mastication, air and liquid leakage into the nasal cavity, and speech; (4) being disease-free at the time of the questionnaire; and (5) an adequate level of literacy to complete the questionnaire instruments. Exclusion criteria were (1) history of mental illness; (2) inability or unwillingness to consent; (3) less than 1 year since surgical resection; and (4) having an implantretained prosthesis. Procedure The study was approved by the Ethics Committee of the Istanbul Faculty of Medicine and conducted in accordance with the principles of the Helsinki Declaration. All patients were informed about the scope of the study by a clinic assistant (A.B.). Informed consent was obtained from each subject who agreed to participate before he or she filled out the questionnaires. After completion of the dental prosthetic examination by a trained clinic assistant (A.B.), data were collected via face-to-face interviews with a trained research assistant (M.O.K.) in the clinic’s waiting room. Of the 54 potentially eligible patients who had had a maxillectomy, 41 (76%) were eligible for this study. Reasons for the exclusion of 13 patients were presence of an ongoing or recurrent disease (n = 3), inadequate literacy level (n = 4), mental handicap (n = 1), having an implant-retained prosthesis (n = 3), and refusal to participate (n = 2). Data acquisition Data were collected from responses to a questionnaire with 2 sections. The first section comprised sociodemographic (gender, age, educational level, employment status, family monthly income) and clinical variables (type of tumor, stage of disease, size of maxillectomy defect,
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degree of resection, condition of premorbid dentition, type of surgery, and radiotherapy). The second section consisted of the Turkish version of the OFS, which was developed by Kornblith et al.10 to assess patient satisfaction with the functioning of the obturator. The OFS comprised 15 items in 3 subscales: (1) eating problems; (2) speech problems; and (3) other problems, such as dry mouth, numbness of the upper lip, difficulties with inserting the obturator, and avoidance of social life. Response categories ranged from 1 (not at all–a little difficult) to 5 (very much–extremely difficult). Scores were transformed on a scale from 0 to 100. Higher scores indicated worse obturator functioning and poorer patient satisfaction. At the time of this study, no Turkish translation of the OFS was available. On the basis of standard recommendations,16 the process of cross-cultural adaptation involved several steps: translation from English to Turkish; an initial meeting of the expert panel to produce the first Turkish version; pilot-testing in a convenience sample of 25 patients; a second meeting of the expert panel to produce a new consensus version; backtranslation to English; and re-evaluation by the expert panel members. The OFS was translated from English to Turkish by 2 native Turkish-speaking translators experienced in translation of health questionnaires. In the first meeting, the expert panel consisted of researchers and translators who examined the 2 versions of the OFS to determine a semi-final translation for testing. This was then reviewed to ensure that the final translation was fully comprehensible and to verify the cross-cultural equivalence of the source and final versions. In addition, the face and content validity of the scale were examined by the expert panel to assess clarity of wording of items. This version was then pilot-tested on a convenience sample of 25 patients who had undergone maxillectomy and oral rehabilitation at our clinic to ensure sensitivity to local culture and choice of appropriate wording. In the second meeting, modifications were made according to comments from the patients and the expert panel members to clarify the content of the questionnaire. In our study, the internal consistency of scale was tested for the entire sample of patients. Minimum sample size for Cronbach’s alpha coefficient was calculated by using Bonnett’s formula 17 : N = ( 2 k [ k − 1]) (zα 2 + z β ) 2 2 In ([1 − p k ] [1 − p k ]) + 2 . In this formula, k (15) is the number of OFS items, p k is the lowest acceptable Cronbach’s alpha value (0.70), and p k (0.88) is a planning value obtained from previous research18; zα/2 and zβ are points on the standard normal distribution exceeded with probability α/2 and β, respectively. Twenty-three patients would be required for testing H0: pk = 0.70 against a 2-sided alternative at α = 0.05 with power of 0.80, where k = 13 and p k = 0.88 .
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Test–retest reliability was assessed by the intraclass correlation coefficient (ICC) at 2-week intervals. On the basis of the method described by Walter et al.,19 a sample size of 39 patients were needed to detect a minimum ICC of 0.6, assuming a desired reliability of 0.8, with a power of 0.8 at a significance level of 0.05. It had excellent internal consistency reliability with a Cronbach’s alpha of 0.85 and demonstrated perfect test–retest reliability (ICC = 0.86). The Cronbach’s alpha for the total score and for the subscales of OFS “eating problems,” “speech problems,” and “other problems” were 0.85, 0.76, 0.72, and 0.81, respectively. Statistical analysis Descriptive statistics were used to summarize the sociodemographic and clinical characteristics. Normality of the OFS items, subscale scores, and total scores were checked using the Kolmogorov-Smirnov test. To explore the relationship between the OFS and patients’ characteristics (sociodemographic and clinical), the MannWhitney U test was used for dichotomous variables and the Spearman’s rank order correlation for continuous variables. Spearman’s correlation coefficients were interpreted as follows: • r ≤ 0.49—weak relationship • 0.50 ≤ r ≤ 0.74—moderate relationship • r ≥ 0.75—strong relationship20 A backward stepwise multiple linear regression was performed to identify factors independently associated with patient satisfaction with the functioning of their obturator prostheses. The independent variables were transformed into dichotomous variables as follows: • Gender—females vs males • Level of education—8 years or less of schooling vs greater than 8 years of schooling • Smoking—yes vs no • Alcohol consumption—yes vs no • Degree of resection—hard palate vs hard palate plus soft palate • Treatment type—surgery alone vs surgery plus radiotherapy • Surgery type—transoral vs transfacial • Defect size—Class II b or smaller vs larger than Class IIb21 • Stage of tumors—early stage (T1, T2) vs advanced (T3, T4) • Dental condition in maxilla—edentate or dentate Monthly family income, wearing time of prosthesis, and age were entered as continuous variables in the model. Statistical significance was achieved when P < .05. Sta-
ORIGINAL ARTICLE Ozdemir-Karatas et al. 3
tistical analysis was performed using IBM SPSS Statistics version 19 for Windows (SPSS Inc., Chicago, IL).
RESULTS Study sample description The sociodemographic and clinical characteristics of patients are shown in Table I. The mean age of patients was 52.48 ± 12.84 years (range 18-77 years). Of the study patients, 58% were men, 61% (n = 25) had formal school education equal to or less than 8 years, 83% were married, 20% consumed alcohol, and 15% were cigarette smokers. The mean monthly family income was 1493 TL (or US $427). Of the 41 patients with maxillary sinus cancer, 16 (39%) had had surgery alone, 8 (19%) had undergone transfacial surgery, 28 patients had undergone hard palate resection, and 32 (78%) were dentate. According to the classification by Brown et al.,21 maxillectomy defects were Class IIb or smaller in 46% (n = 19) and larger than Class IIb in 54% of patients (n = 22). All of these patients had malignant tumor. Tumor classification, according to the American Joint Committee on Cancer staging system, was T1 in 11 patients, T2 in 15 patients, T3 in 11 patients, and T4 in 4 patients. The node (N) classification was N0 in 26 patients, N1 in 12 patients, N2a in 2 patient, and N2b in 1 patient (data not shown). The most frequent histologic diagnoses were squamous cell carcinoma (n = 29 [71%]), adenocystic carcinoma (n = 7 [17%]), mucoepidermoid carcinoma (n = 4 [10%]), and ameloblastoma (n = 1 [2%]). The most frequently reported problems were “difficulty in chewing” (48.8%), “difficulty in inserting the obturator” (41.5%), “dissatisfaction with the appearance” (39%), “noticeable clasps on front teeth visible” (39%), “dry mouth” (36.6%), “difficulty in understandibility of speech” (36.6%), and “leakage when swallowing foods” (36.6%). A total of Table I. Sociodemographic and behavioral characteristics of patients (n = 41) Characteristics Gender
Female Male Marital status Married Single, divorced, or widowed Employment status Employed full or part-time Unemployed Family monthly income, TL, mean ± SD Educational level ≤8 years of schooling >8 years of schooling Age (y), mean ± SD Smoking after tumor Yes treatment No Alcohol after tumor Yes treatment No SD, standard deviation; TL, Turkish Lira.
n (%) 17 24 34 7
(41.5) (58.5) (82.9) (17.1)
15 (36.6) 26 (63.4) 1493.17 ± 1109.23 25 (61) 16 (39) 52.48 ± 12.84 6 (14.6) 35 (85.4) 8 (19.5) 33 (80.5)
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14 patients (34.1%) had nasal speech, 34.1% felt they had a funny-looking upper lip, 31.7% had difficulty pronouncing words, 26.8% avoided family/social events, 26.8% had difficulty talking in public, and 19.5% experienced leakage of food while eating. Patients reported the least difficulty with numbness in the upper lip (2.4%) and voice change following surgery (12.2%) (data not shown). Item-based analysis showed that patients with greater than 8 years of schooling reported more problems with leakage when swallowing foods (P = .042) and problems with clasps on front teeth compared with those with 8 years of schooling or less (P = .033). Patients with advanced tumors had higher scores on items 7 (difficulty pronouncing words; P = .031) and 12 (upper lip feels numb; P = .032) compared with those with early-stage tumors. Patients treated with transfacial surgery had more problems, including dissatisfaction with their appearance (P = .035), chewing food (P = .002), leakage when swallowing liquids (P = .048) and solids (P = .006), having clasps on front teeth (P > .001), and numbness in the upper lip (P > .001) compared with those treated by transoral surgery. Patients with maxillectomy defect sizes larger than Class IIb reported more problems associated with xerostomia (P = .037), nasal speech (P > .001), clasps on front teeth (P > .001), and numbness in the upper lip (P = .029) compared with those with maxillectomy defect sizes Class IIb and smaller. Patients who had received radiation therapy had significantly higher scores for xerostomia compared with patients treated by surgery alone (P = .009). Dentate patients reported more problems with understandability of speech (P = .045), and were dissatisfied with their appearance compared with edentate patients (P = .044). Patients who consumed alcohol reported higher scores for dry mouth (P = .015), and patients who had hard palate resection reported less difficulty with enunciating words (P = .001). Item 14, related to difficulty with inserting the obturator, was negatively correlated with age (r = −0.45; P < .01) (data not shown). We found significant differences in total OFS scores in terms of surgery type, defect size, and education level (Table II). Patients who had undergone transfacial surgery had higher total OFS scores, higher “eating” subscale scores, and higher scores on the remaining items compared with those who had undergone transoral surgery. Patients with maxillectomy defect sizes Class IIb and smaller had significantly lower total OFS scores, and its subscale consisted of remaining items compared with those with Class IIb or more defects. The initial full model that included all independent variables explained 42.7% of the variance of patient satisfaction with the functioning of the obturator (Table III). Backward multiple linear regression analysis showed that the independent variables of education level (β = 0.29; P = .031) and surgery type (β = 0.47; P = .001) remained the best predictive model for patient
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satisfaction with the functioning of the obturator, explaining 34% of the variance of patient satisfaction. Other variables were able to add only 8.7% into the prediction.
DISCUSSION In recent years, there has been a growing interest in evaluating HRQOL among Turkish patients with head and neck cancer. However, to date, only 2 studies have examined HRQOL using condition-specific measures in Turkish patients with head and neck cancer who underwent different oral rehabilitation modalities.22,23 To the best of our knowledge, there is no study evaluating the HRQOL of patients who had undergone maxillectomy and rehabilitated with obturator prostheses and the effect of prosthodontic therapy with obturator prostheses on their HRQOL. It is known that prosthetic obturator rehabilitation after maxillectomy is a positive and noninvasive approach to improve the oronasal functions, resocialization, and HRQOL of patients with maxillectomy defects.3,4,6,24 In these patients, impaired functioning and handling of the obturator may lead to difficulties with speech, mastication, and swallowing or facial disfigurement, thereby decreasing patient satisfaction.4,7 This is the first study to evaluate HRQOL using the OFS in Turkish patients rehabilitated with maxillary obturator prostheses after maxillectomy. We used the OFS for the evaluation of HRQOL because this function- and performance-specific questionnaire may be used to identify patients at risk for poor HRQOL and to determine patient satisfaction and unmet functional and social needs related to prosthetic rehabilitation.5,7,8,10,25 Bivariate analyses showed that patients with less than 8 years of schooling reported significantly better obturator functioning, less difficulty swallowing solid foods, lower dissatisfaction with noticeable clasps compared with those with 8 years or more of schooling, and older patients had more problems with insertion of their prostheses. These results may be explained by the fact that older patients had difficulty inserting prostheses because of reduced psychomotor skills, and patients with higher education level would be more concerned with their health and aware of their body image.26,27 However, some studies reported contradicting findings about the association between sociodemographic factors and obturator functioning. Gupta et al.11 found that obturator functioning was significantly related to educational status. Some researchers did not find any differences in obturator functioning in terms of age and gender,6,11 whereas Chen et al.18 reported that patients age 60 years and over reported more problems with swallowing solids and that women had lower appearance scores compared with men. In addition, Rieger et al.25 reported that women experienced greater changes in voice compared with men. Smoking and alcohol consumption were not associated
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ORIGINAL ARTICLE Ozdemir-Karatas et al. 5
Table II. Comparison of the OFS and its subscale scores according to sociodemographic, clinical and behavioral variables (n = 41) Variables Gender*
Male (n = 24) Female (n = 17)
Marital status*
Single (n = 7) Married (n = 34)
Employment status*
Employed (n = 15) Unemployed (n = 26)
Educational level*
≤8 years (n = 25) >8 years (n = 16)
Smoking after tumor treatment*
Yes (n = 6) No (n = 35
Alcohol after tumor treatment*
No (n = 33) Yes (n = 8)
Treatment type*
Surgery alone (n = 16) Surgery + radiotherapy (n = 25)
Surgery type*
Transoral (n = 33) Transfacial (n = 8)
Defect size*
Class ≤ 2b (n = 19) Class > 2b (n = 22)
Stage of disease*
Early stage (n = 26) Advanced (n = 15)
Dental condition in maxilla*
Dentate (n = 32) Edentate (n = 9)
Degree of resection*
HP (n = 29) HP + SP (n = 12)
Age (y), r Family monthly income, r
OFS total Mean ± SD
OFS eating Mean ± SD
OFS speech Mean ± SD
OFS other Mean ± SD
38.19 ± 21.48 35.49 ± 17.75 P = .822 39.52 ± 15.08 36.56 ± 30.83 P = .615 34.00 ± 19.64 38.84 ± 20.10 P = .408 31.60 ± 19.00 45.62 ± 18.52 P = .026 37.77 ± 20.18 36.95 ± 20.07 P = .868 37.17 ± 19.91 36.66 ± 20.85 P = .947 33.75 ± 21.32 39.20 ± 18.96 P = .429 32.22 ± 18.81 57.08 ± 7.85 P = .001 29.82 ± 21.18 43.33 ± 16.61 P = .021 34.10 ± 18.65 42.22 ± 21.40 P = .260 35.52 ± 20.73 42.59 ± 16.05 P = .305 34.25 ± 20.01 43.88 ± 18.41 P = .182 −0.177 0.134
40.97 ± 29.88 38.23 ± 30.48 P = .777 38.09 ± 36.91 40.19 ± 28.75 P = .916 32.22 ± 33.01 44.23 ± 27.46 P = .172 34.66 ± 26.75 47.91 ± 33.26 P = .177 44.44 ± 36.00 39.04 ± 29.13 P = .763 39.39 ± 29.40 41.66 ± 33.33 P = .933 37.50 ± 28.86 41.33 ± 30.85 P = .692 34.84 ± 30.72 60.41 ± 12.40 P = .011 35.08 ± 32.81 43.93 ± 26.99 P = .235 39.10 ± 24.46 41.11 ± 38.24 P = .989 37.50 ± 32.24 48.14 ± 17.56 P = .222 36.78 ± 29.33 4722 ± 30.84 P = .273 0.053 0.079
35.41 ± 23.95 35.88 ± 27.85 P = .947 41.42 ± 19.51 34.41 ± 26.42 P = .327 35.33 ± 24.16 35.76 ± 26.40 P = .967 29.20 ± 21.96 45.62 ± 27.56 P = .062 36.66 ± 21.60 35.42 ± 26.16 P = .766 35.75 ± 26.69 35.00 ± 20.00 P = .934 34.37 ± 28.74 36.40 ± 23.43 P = .666 32.42 ± 24.87 48.75 ± 24.16 P = .065 31.05 ± 26.85 39.54 ± 23.80 P = .200 31.92 ± 25.77 42.00 ± 23.96 P = .163 35.31 ± 25.90 36.66 ± 24.49 P = .787 30.34 ± 21.95 48.33 ± 29.18 P = .062 −0.073 0.082
38.98 ± 23.82 34.03 ± 16.07 P = .416 38.77 ± 16.42 36.55 ± 21.87 P = .930 33.80 ± 22.17 38.73 ± 20.32 P = .453 32.00 ± 22.12 44.64 ± 16.59 P = .058 35.71 ± 24.74 37.14 ± 20.55 P = .941 37.22 ± 20.41 35.71 ± 24.14 P = .765 31.69 ± 21.02 40.28 ± 20.50 P = .157 30.95 ± 18.35 61.60 ± 9.30 P = .000 26.69 ± 20.59 45.77 ± 17.02 P = .004 33.51 ± 19.45 42.85 ± 22.58 P = .177 34.82 ± 21.06 44.44 ± 19.48 P = .260 35.96 ± 22.54 39.28 ± 16.82 P = .058 −0.675 0.088
HP, hard palate; HP + SP, hard + soft palate; OFS, obturator functioning scale; r, spearman’s rank correlation coefficient; SD, standard deviation. *Statistical evaluation by Mann-Whitney U test.
Table III. Predictors of worse obturator functioning and satisfaction (n = 41) Best model (R2 = 0.340; F = 9.792; P < .001) Educational level† Surgery type†
β*
t
P value
0.297 0.470
2.241 3.544
.031 .001
*Standardized beta coefficients are presented. † Dichotomized variables: Gender (0, ≤8 years of schooling; 1, >8 years of schooling). Surgery type (0, transoral; 1, transfacial).
with overall functioning of and satisfaction with obturator prostheses in these patients. Clinical factors, such as soft palate resection, cancer stage, premorbid dentition, and postoperative radiation
therapy, were not associated with OFS total and subscale scores in this study. In contrast to our results, previous studies reported that postoperative radiation therapy,6,18,25 premorbid dentition,5,18 and degree of resection,10,25 were the most significant predictors of better obturator functioning in patients who had undergone maxillectomy and were rehabilitated with maxillary obturator prostheses. Earlier studies reported that the size of the maxillectomy10,27,28 and surgical approach8-10 were associated with oral functioning. Consistent with previous studies, we found that patients who underwent transfacial surgery reported significantly higher scores on the total OFS and the “eating” subscale compared with those who underwent transoral surgery.8-10 In addition, these patients had worse scores for 5 items (difficulty chewing
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foods, leakage while swallowing, dissatisfaction with appearance, noticeable clasps on front teeth, and numb upper lip). This is not surprising because patients treated with transfacial surgery experience some specific functional and aesthetic problems because of scar formation and contracture in their upper lip.28 Our study patients with larger defect sizes had worse scores for overall obturator functioning and for 4 other items (xerostomia, nasal speech, clasps on front teeth, and numbness in upper lip) compared with those with smaller defects. Similar findings were reported by Kornblith et al.,10 who found that patients who had no more than one-third of the soft palate and one-fourth of the hard palate resected had better speech scores and overall obturator function. In the study by Chen et al.,18 patients with larger defects faced more problems with swallowing solids and nasal regurgitation of fluids or solids while eating or drinking. These difficulties may be caused by inadequate retention and stability of the prosthesis leading to worse functional outcomes and patient dissatisfaction. However, some contradictory findings have been reported regarding the influence of these clinical factors in patient satisfaction and obturator functioning.6,7,9 These contradictions may be attributed to the difference in study designs, sample sizes, and patient-related characteristics. The sample size in our study was lower than those in the studies conducted by Seignemartin et al., 28 Khan et al., 29 and Kornblith et al.10 The mean age of our patients was 52.48 ± 12.84 years. This finding is similar to those of the studies by Depprich et al.,7 Irish et al.,8 and Gupta et al.11 Compared with the patients in previous studies,2,10,25 our patients reported more problems with chewing, but less than those reported by Khan et al.29 The percentage of patients who had leakage while swallowing was also higher in our study compared with previous studies.10,25,29 Our patients reported fewer problems with voice change and dry mouth compared with those in previous studies.8,10,25,29 This may be related to the small number of patients in our study who had had soft palate resection. The number of patients who had nasal speech and who reported difficulty enunciating words was higher than those in previous studies.8,10,25,29 Our patients reported more difficulties with talking in public and avoiding family/social events compared with patients in previous studies.8,10,25,29 It should be noted that our patients experienced more difficulty inserting their obturators than that reported in previous studies. The differences between the results of earlier studies and this study may be attributed to the patient-related characteristics (e.g., clinical, psychological, and psychomotor factors and social and cultural beliefs). To the best of our knowledge, this was the first study using the OFS to determine the clinical and sociodemographic factors affecting the functioning of and patient
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satisfaction with obturators in Turkish patients who had undergone maxillectomy and were rehabilitated with obturator prostheses. The Turkish version of the OFS showed satisfactory internal consistency and test–retest reliability. However, our study had some limitations. The crosssectional design could not explain causation and changes over time in patient satisfaction and obturator functioning. The retrospective design of this study did not permit preoperative assessment of HRQOL. Future longitudinal studies using the OFS may provide valuable information for the maxillofacial prosthetic team in assessing self-perceived changes in the HRQOL of these patients. This study was conducted with a convenience sample of maxillectomy patients rehabilitated with conventional obturator prostheses at the Prosthodontics Clinic of our faculty, limiting the generalizability of the results and the conclusions. Maxillectomy patients who received free flap reconstruction and those who were rehabilitated with implant-supported obturator prostheses were not included in this study because of the small number of patients. Well-designed clinical studies are necessary to evaluate the impacts of different types of obturators and retention mechanisms on the functional quality of the obturator prosthesis and patient satisfaction. Earlier studies5-8,10,25 investigating the relationship between obturator functioning and psychological factors (i.e., psychological distress, anxiety, depression, and loss of behavioral control) have reported the importance of integrating psychological care into the treatment plan. In future studies, adding a generic HRQOL measure to the OFS may provide greater insight into the emotional and psychological needs of these patients because this information is important to clinicians in the development of a comprehensive treatment plan.8,10 Although there has been an increase in HRQOL studies, only a small number of studies has examined the influence of clinical and sociodemographic factors on patients’ HRQOL.11,18,29 To date, only 1 study, by Depprich et al., has evaluated the relationship between sociodemographic and behavioral factors and their impact on patients’ HRQOL.7 The strengths of this study include the wide range of sociodemographic and behavioral data as well as the use of a validated HRQOL.
CONCLUSIONS The results of our study indicate that the education level and surgery type were the most important predictors for worse obturator functioning and poor patient satisfaction in Turkish patients who had undergone maxillectomy. The Turkish version of the OFS may be a useful tool for clinicians to identify Turkish patients who are at risk for poor HRQOL and their unmet needs and to develop a comprehensive prosthodontic rehabilitation program. The authors wish to thank all the patients who participated in the study, and Dr. Didem Ozdemir-Ozenen and Dr. Elif
ARTICLE IN PRESS OOOO Volume ■■, Number ■■ Sungurtekin Ekci for their assistance with editing this manuscript. REFERENCES 1. Pace-Balzan A, Rogers SN. Dental rehabilitation after surgery for oral cancer. Curr Opin Otolaryngol Head Neck Surg. 2012;20: 109-113. 2. Lethaus B, Lie N, de Beer F, Kessler P, de Baat C, Verdonck HW. Surgical and prosthetic reconsiderations in patients with maxillectomy. J Oral Rehabil. 2010;37:138-142. 3. Salinas TJ. Prosthetic rehabilitation of defects of the head and neck. Semin Plast Surg. 2010;24:299-308. 4. Kumar P, Alvi HA, Rao J, et al. Assessment of the quality of life in maxillectomy patients: a longitudinal study. J Adv Prosthodont. 2013;5:29-35. 5. Riaz N, Warriach RA. Quality of life in patients with obturator prostheses. J Ayub Med Coll Abbottabad. 2010;22:121-125. 6. Chigurupati R, Aloor N, Salas R, Schmidt BL. Quality of life after maxillectomy and prosthetic obturator rehabilitation. J Oral Maxillofac Surg. 2013;71:1471-1478. 7. Depprich R, Naujoks C, Lind D, et al. Evaluation of the quality of life of patients with maxillofacial defects after prosthodontic therapy with obturator prostheses. Int J Oral Maxillofac Surg. 2011; 40:71-79. 8. Irish J, Sandhu N, Simpson C, et al. Quality of life in patients with maxillectomy prostheses. Head Neck. 2009;31:813-821. 9. Kreeft AM, Krap M, Wismeijer D, et al. Oral function after maxillectomy and reconstruction with an obturator. Int J Oral Maxillofac Surg. 2012;41:1387-1392. 10. Kornblith AB, Zlotolow IM, Gooen J, et al. Quality of life of maxillectomy patients using an obturator prosthesis. Head Neck. 1996;18:323-334. 11. Gupta R, Luthra RP, Gupta S. Evaluation of quality of life of maxillectomy patients after prosthetic obturator rehabilitation. Int Dent Med J Adv Res. 2016;2:1-4. 12. Cawood JI, Stoelinga PJ, International Academy for Oral and Facial Rehabilitation. International Academy for Oral and Facial Rehabilitation—consensus report. Int J Oral Maxillofac Surg. 2006; 35:195-198. 13. Kanatas AN, Rogers SN. A systematic review of patient selfcompleted questionnaires suitable for oral and maxillofacial surgery. Br J Oral Maxillofac Surg. 2010;48:579-590. 14. Murphy BA, Ridner S, Wells N, Dietrich M. Quality of life research in head and neck cancer: a review of the current state of the science. Crit Rev Oncol Hematol. 2007;62:251-267. 15. Beumer J, Curtis TA, Marunick MT. Maxillofacial Rehabilitation: Prosthodontic and Surgical Considerations. St. Louis, MO: Ishiyaku EuroAmerica Inc.; 1996:279. 16. Guillemin F, Bombardier C, Beaton D. Cross cultural adaptation of health-related quality of life measures: literature and proposed guidelines. J Clin Epidemiol. 1993;46:1417-1432. 17. Bonett DG. Sample size requirements for testing and estimating coefficient alpha. J Educ Behav Stat. 2002;27:335-340.
ORIGINAL ARTICLE Ozdemir-Karatas et al. 7 18. Chen C, Ren WH, Huang RZ, et al. Quality of life in patients after maxillectomy and placement of prosthetic obturator. Int J Prosthodont. 2016;29:363-368. 19. Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998;17:101-110. 20. Portney LG, Watkins MP. Foundations of Clinical Research. Applications to Practice. 2nd ed. Upper Saddle River, NJ: Prentice Hall; 2000. 21. Brown JS, Shaw RJ. Reconstruction of the maxilla and midface: introducing a new classification. Lancet Oncol. 2010;11:10011008. 22. Peker K, Ozdemir-Karatas M, Balık A, Kürklü E, Uysal O, Rogers SN. Validation of the Turkish version of the Liverpool Oral Rehabilitation Questionnaire version 3 (LORQv3) in prosthetically rehabilitated patients with head and neck cancer. BMC Oral Health. 2014;14:129. 23. Nemli SK, Aydin C, Yilmaz H, Bal BT, Arici YK. Quality of life of patients with implant-retained maxillofacial prostheses: a prospective and retrospective study. J Prosthet Dent. 2013;109:4452. 24. Goiato MC, Pesqueira AA, Ramos da Silva C, Gennari Filho H, Micheline Dos Santos D. Patient satisfaction with maxillofacial prosthesis. Literature review. J Plast Reconstr Aesthet Surg. 2009; 62:175-180. 25. Rieger JM, Wolfaardt JF, Jha N, Seikaly H. Maxillary obturators: the relationship between patient satisfaction and speech outcome. Head Neck. 2003;25:895-903. 26. Bilal S, Doss JG, Cella D, Rogers SN. Quality of life associated factors in head and neck cancer patients in a developing country using the FACT-H&N. J Craniomaxillofac Surg. 2015;43:274280. 27. Rogers SN, Lowe D, McNally D, Brown JS, Vaughan ED. Healthrelated QOL after maxillectomy: a comparison between prosthetic obturation and free flap. J Oral Maxillofac Surg. 2003;61:174181. 28. Seignemartin CP, Miranda ME, Luz JG, Teixeira RG. Understandability of speech predicts quality of life among maxillectomy patients restored with obturator prosthesis. J Oral Maxillofac Surg. 2015;73:2040-2048. 29. Khan MWU, Shah AA, Fatima A, Hanif A. Subjective assessment of obturator functioning in patients with hemimaxillectomy. Pakistan J Med Health Sci. 2014;8:694-697.
Reprint requests: Meltem Ozdemir-Karatas, PhD, DDS Department of Prosthodontics Faculty of Dentistry Istanbul University Capa Istanbul Turkey [email protected].
Predictors of obturator functioning and satisfaction in Turkish patients using an obturator prosthesis after maxillectomy Meltem Ozdemir-Karatas, PhD, DDS,a Ali Balik, PhD, DDS,a Gülümser Evlioglu, PhD, DDS,a Ömer Uysal, PhD,b and Kadriye Peker, PhDc Objective. The aim of this study was to determine the sociodemographic, behavioral, and clinical factors affecting obturator function and satisfaction using the obturator functioning scale (OFS) in maxillectomy patients rehabilitated with obturator prostheses. Study Design. The study sample consisted of 41 maxillectomy patients. The OFS was translated into Turkish and adapted for assessing obturator functioning and patient satisfaction among Turkish patients. Data were collected from patients’ medical records and self-completed questionnaires, including the Turkish version of the OFS, sociodemographic and behavioral characteristics. Descriptive statistics, Mann-Whitney U test, Spearman’s correlation coefficient, and backward stepwise multiple linear regression were used for data analysis. Results. Internal consistency (Cronbach’s alpha = 0.85) and test–retest reliability (intraclass correlation coefficient = 0.86) were acceptable for the OFS. The most frequently reported problem was “difficulty chewing.” Bivariate analysis revealed significant differences in total OFS scores in terms of surgery type, defect size, and education level, except for the other clinical and sociodemographic characteristics and behavioral factors. Education level and surgery type were found to be the most important predictors of patient satisfaction and functioning of the obturator. Conclusions. The Turkish version of the OFS might be a useful tool for clinicians to identify patients who are at risk for poor functioning of the obturator, lack of satisfaction, and unmet needs. (Oral Surg Oral Med Oral Pathol Oral Radiol 2017;■■:■■–■■)
In recent years, health-related quality of life (HRQOL) and treatment satisfaction have been progressively acknowledged as patient-reported outcome measures in the prosthetic rehabilitation of patients with head and neck cancer.1,2 After resection of maxillofacial tumors, patients have to deal with orofacial functional problems and emotional issues that might have significant negative effects on the HRQOL of patients and their caregivers. In the management of maxillary defects, obturator prosthesis is the most widely used noninvasive approach to restore the patient’s oral functions, aesthetics, and resocialization.3-5 There are several studies examining patients’ HRQOL and its relationship to obturator functioning.4-11 However, to our knowledge, there are no published studies evaluating the functioning of the obturator and the satisfaction of Turkish patients with obturator prostheses after total maxillectomy. In previous studies, generic HRQOL measures were commonly used in combination with HRQOL measures for head and neck cancer, and HRQOL measures specific for oral health were used for assessing the treatment outcomes of oral rehabilitation. A recent consensus report on orofacial rehabilitation12 and a structured
review of studies reporting specific functions in patients with head and neck cancer states that more sensitive and specific measures are needed for assessing the impacts of oral rehabilitation on patients’ HRQOL because the existing measures seem to lack the discriminating ability to measure the effects of oral rehabilitation on HRQOL in these cases.13 Recognizing the importance of oronasal functions on HRQOL outcomes, the obturator functioning scale (OFS) was developed at the Memorial Sloan Kettering Cancer Center with the aim to assess the selfreported functioning of and satisfaction with the obturator prosthesis in maxillectomy patients.10 Besides clinical parameters, using this subsite and performance-based specific HRQOL measure may provide useful information about patients’ unmet needs and expectations, as well as the effectiveness of the prosthodontic treatment.13 Reconstruction with a prosthetic obturator is the most preferred method in Turkey. Our institutional experience has indicated that many patients are dissatisfied with their obturator prostheses and its poor functionality. It is known that evaluation of HRQOL and functional outcomes after prosthetic rehabilitation of patients with head and neck cancer is critical for optimal patient care and
a
Department of Prosthodontics, Faculty of Dentistry, Istanbul University, Capa, Istanbul, Turkey. b Department of Medical Statistics and Informatics, Medical School, Bezmialem Vakif University, Fatih, Istanbul, Turkey. c Department of Dental Public Health, Faculty of Dentistry, Istanbul University, Capa, Istanbul, Turkey. Received for publication Aug 10, 2017; returned for revision Oct 24, 2017; accepted for publication Nov 4, 2017. © 2017 Elsevier Inc. All rights reserved. 2212-4403/$ - see front matter https://doi.org/10.1016/j.oooo.2017.11.002
Statement of Clinical Relevance This study aimed to investigate the causes of problems with chewing and swallowing, food leakage, and speech problems in patients with head and neck cancer and to increase the quality of life of these patients by proposing solutions to these problems. 1
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comprehensive evaluation of treatment options.14 Thus, this pilot study aimed to determine the sociodemographic and clinical factors affecting functioning of and satisfaction with obturator prostheses using the OFS in Turkish patients rehabilitated with maxillary obturator prostheses after maxillectomy.
MATERIALS AND METHODS Forty-one patients who had undergone maxillectomy and been rehabilitated with obturator prostheses at the Prosthodontics Clinic of a dental teaching hospital in Istanbul, Turkey, were recruited to participate in this crosssectional study. Patients were selected consecutively during their annual checkup visits to our hospital between January 4 and April 30, 2014. The inclusion criteria for maxillectomy patients were (1) age 18 years or over; (2) use of a definite obturator prosthesis for at least 6 months; (3) having a clinically and functionally acceptable prosthesis, according to the criteria defined by Beumer et al.,15 including consideration of efficiency of mastication, air and liquid leakage into the nasal cavity, and speech; (4) being disease-free at the time of the questionnaire; and (5) an adequate level of literacy to complete the questionnaire instruments. Exclusion criteria were (1) history of mental illness; (2) inability or unwillingness to consent; (3) less than 1 year since surgical resection; and (4) having an implantretained prosthesis. Procedure The study was approved by the Ethics Committee of the Istanbul Faculty of Medicine and conducted in accordance with the principles of the Helsinki Declaration. All patients were informed about the scope of the study by a clinic assistant (A.B.). Informed consent was obtained from each subject who agreed to participate before he or she filled out the questionnaires. After completion of the dental prosthetic examination by a trained clinic assistant (A.B.), data were collected via face-to-face interviews with a trained research assistant (M.O.K.) in the clinic’s waiting room. Of the 54 potentially eligible patients who had had a maxillectomy, 41 (76%) were eligible for this study. Reasons for the exclusion of 13 patients were presence of an ongoing or recurrent disease (n = 3), inadequate literacy level (n = 4), mental handicap (n = 1), having an implant-retained prosthesis (n = 3), and refusal to participate (n = 2). Data acquisition Data were collected from responses to a questionnaire with 2 sections. The first section comprised sociodemographic (gender, age, educational level, employment status, family monthly income) and clinical variables (type of tumor, stage of disease, size of maxillectomy defect,
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degree of resection, condition of premorbid dentition, type of surgery, and radiotherapy). The second section consisted of the Turkish version of the OFS, which was developed by Kornblith et al.10 to assess patient satisfaction with the functioning of the obturator. The OFS comprised 15 items in 3 subscales: (1) eating problems; (2) speech problems; and (3) other problems, such as dry mouth, numbness of the upper lip, difficulties with inserting the obturator, and avoidance of social life. Response categories ranged from 1 (not at all–a little difficult) to 5 (very much–extremely difficult). Scores were transformed on a scale from 0 to 100. Higher scores indicated worse obturator functioning and poorer patient satisfaction. At the time of this study, no Turkish translation of the OFS was available. On the basis of standard recommendations,16 the process of cross-cultural adaptation involved several steps: translation from English to Turkish; an initial meeting of the expert panel to produce the first Turkish version; pilot-testing in a convenience sample of 25 patients; a second meeting of the expert panel to produce a new consensus version; backtranslation to English; and re-evaluation by the expert panel members. The OFS was translated from English to Turkish by 2 native Turkish-speaking translators experienced in translation of health questionnaires. In the first meeting, the expert panel consisted of researchers and translators who examined the 2 versions of the OFS to determine a semi-final translation for testing. This was then reviewed to ensure that the final translation was fully comprehensible and to verify the cross-cultural equivalence of the source and final versions. In addition, the face and content validity of the scale were examined by the expert panel to assess clarity of wording of items. This version was then pilot-tested on a convenience sample of 25 patients who had undergone maxillectomy and oral rehabilitation at our clinic to ensure sensitivity to local culture and choice of appropriate wording. In the second meeting, modifications were made according to comments from the patients and the expert panel members to clarify the content of the questionnaire. In our study, the internal consistency of scale was tested for the entire sample of patients. Minimum sample size for Cronbach’s alpha coefficient was calculated by using Bonnett’s formula 17 : N = ( 2 k [ k − 1]) (zα 2 + z β ) 2 2 In ([1 − p k ] [1 − p k ]) + 2 . In this formula, k (15) is the number of OFS items, p k is the lowest acceptable Cronbach’s alpha value (0.70), and p k (0.88) is a planning value obtained from previous research18; zα/2 and zβ are points on the standard normal distribution exceeded with probability α/2 and β, respectively. Twenty-three patients would be required for testing H0: pk = 0.70 against a 2-sided alternative at α = 0.05 with power of 0.80, where k = 13 and p k = 0.88 .
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Test–retest reliability was assessed by the intraclass correlation coefficient (ICC) at 2-week intervals. On the basis of the method described by Walter et al.,19 a sample size of 39 patients were needed to detect a minimum ICC of 0.6, assuming a desired reliability of 0.8, with a power of 0.8 at a significance level of 0.05. It had excellent internal consistency reliability with a Cronbach’s alpha of 0.85 and demonstrated perfect test–retest reliability (ICC = 0.86). The Cronbach’s alpha for the total score and for the subscales of OFS “eating problems,” “speech problems,” and “other problems” were 0.85, 0.76, 0.72, and 0.81, respectively. Statistical analysis Descriptive statistics were used to summarize the sociodemographic and clinical characteristics. Normality of the OFS items, subscale scores, and total scores were checked using the Kolmogorov-Smirnov test. To explore the relationship between the OFS and patients’ characteristics (sociodemographic and clinical), the MannWhitney U test was used for dichotomous variables and the Spearman’s rank order correlation for continuous variables. Spearman’s correlation coefficients were interpreted as follows: • r ≤ 0.49—weak relationship • 0.50 ≤ r ≤ 0.74—moderate relationship • r ≥ 0.75—strong relationship20 A backward stepwise multiple linear regression was performed to identify factors independently associated with patient satisfaction with the functioning of their obturator prostheses. The independent variables were transformed into dichotomous variables as follows: • Gender—females vs males • Level of education—8 years or less of schooling vs greater than 8 years of schooling • Smoking—yes vs no • Alcohol consumption—yes vs no • Degree of resection—hard palate vs hard palate plus soft palate • Treatment type—surgery alone vs surgery plus radiotherapy • Surgery type—transoral vs transfacial • Defect size—Class II b or smaller vs larger than Class IIb21 • Stage of tumors—early stage (T1, T2) vs advanced (T3, T4) • Dental condition in maxilla—edentate or dentate Monthly family income, wearing time of prosthesis, and age were entered as continuous variables in the model. Statistical significance was achieved when P < .05. Sta-
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tistical analysis was performed using IBM SPSS Statistics version 19 for Windows (SPSS Inc., Chicago, IL).
RESULTS Study sample description The sociodemographic and clinical characteristics of patients are shown in Table I. The mean age of patients was 52.48 ± 12.84 years (range 18-77 years). Of the study patients, 58% were men, 61% (n = 25) had formal school education equal to or less than 8 years, 83% were married, 20% consumed alcohol, and 15% were cigarette smokers. The mean monthly family income was 1493 TL (or US $427). Of the 41 patients with maxillary sinus cancer, 16 (39%) had had surgery alone, 8 (19%) had undergone transfacial surgery, 28 patients had undergone hard palate resection, and 32 (78%) were dentate. According to the classification by Brown et al.,21 maxillectomy defects were Class IIb or smaller in 46% (n = 19) and larger than Class IIb in 54% of patients (n = 22). All of these patients had malignant tumor. Tumor classification, according to the American Joint Committee on Cancer staging system, was T1 in 11 patients, T2 in 15 patients, T3 in 11 patients, and T4 in 4 patients. The node (N) classification was N0 in 26 patients, N1 in 12 patients, N2a in 2 patient, and N2b in 1 patient (data not shown). The most frequent histologic diagnoses were squamous cell carcinoma (n = 29 [71%]), adenocystic carcinoma (n = 7 [17%]), mucoepidermoid carcinoma (n = 4 [10%]), and ameloblastoma (n = 1 [2%]). The most frequently reported problems were “difficulty in chewing” (48.8%), “difficulty in inserting the obturator” (41.5%), “dissatisfaction with the appearance” (39%), “noticeable clasps on front teeth visible” (39%), “dry mouth” (36.6%), “difficulty in understandibility of speech” (36.6%), and “leakage when swallowing foods” (36.6%). A total of Table I. Sociodemographic and behavioral characteristics of patients (n = 41) Characteristics Gender
Female Male Marital status Married Single, divorced, or widowed Employment status Employed full or part-time Unemployed Family monthly income, TL, mean ± SD Educational level ≤8 years of schooling >8 years of schooling Age (y), mean ± SD Smoking after tumor Yes treatment No Alcohol after tumor Yes treatment No SD, standard deviation; TL, Turkish Lira.
n (%) 17 24 34 7
(41.5) (58.5) (82.9) (17.1)
15 (36.6) 26 (63.4) 1493.17 ± 1109.23 25 (61) 16 (39) 52.48 ± 12.84 6 (14.6) 35 (85.4) 8 (19.5) 33 (80.5)
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14 patients (34.1%) had nasal speech, 34.1% felt they had a funny-looking upper lip, 31.7% had difficulty pronouncing words, 26.8% avoided family/social events, 26.8% had difficulty talking in public, and 19.5% experienced leakage of food while eating. Patients reported the least difficulty with numbness in the upper lip (2.4%) and voice change following surgery (12.2%) (data not shown). Item-based analysis showed that patients with greater than 8 years of schooling reported more problems with leakage when swallowing foods (P = .042) and problems with clasps on front teeth compared with those with 8 years of schooling or less (P = .033). Patients with advanced tumors had higher scores on items 7 (difficulty pronouncing words; P = .031) and 12 (upper lip feels numb; P = .032) compared with those with early-stage tumors. Patients treated with transfacial surgery had more problems, including dissatisfaction with their appearance (P = .035), chewing food (P = .002), leakage when swallowing liquids (P = .048) and solids (P = .006), having clasps on front teeth (P > .001), and numbness in the upper lip (P > .001) compared with those treated by transoral surgery. Patients with maxillectomy defect sizes larger than Class IIb reported more problems associated with xerostomia (P = .037), nasal speech (P > .001), clasps on front teeth (P > .001), and numbness in the upper lip (P = .029) compared with those with maxillectomy defect sizes Class IIb and smaller. Patients who had received radiation therapy had significantly higher scores for xerostomia compared with patients treated by surgery alone (P = .009). Dentate patients reported more problems with understandability of speech (P = .045), and were dissatisfied with their appearance compared with edentate patients (P = .044). Patients who consumed alcohol reported higher scores for dry mouth (P = .015), and patients who had hard palate resection reported less difficulty with enunciating words (P = .001). Item 14, related to difficulty with inserting the obturator, was negatively correlated with age (r = −0.45; P < .01) (data not shown). We found significant differences in total OFS scores in terms of surgery type, defect size, and education level (Table II). Patients who had undergone transfacial surgery had higher total OFS scores, higher “eating” subscale scores, and higher scores on the remaining items compared with those who had undergone transoral surgery. Patients with maxillectomy defect sizes Class IIb and smaller had significantly lower total OFS scores, and its subscale consisted of remaining items compared with those with Class IIb or more defects. The initial full model that included all independent variables explained 42.7% of the variance of patient satisfaction with the functioning of the obturator (Table III). Backward multiple linear regression analysis showed that the independent variables of education level (β = 0.29; P = .031) and surgery type (β = 0.47; P = .001) remained the best predictive model for patient
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satisfaction with the functioning of the obturator, explaining 34% of the variance of patient satisfaction. Other variables were able to add only 8.7% into the prediction.
DISCUSSION In recent years, there has been a growing interest in evaluating HRQOL among Turkish patients with head and neck cancer. However, to date, only 2 studies have examined HRQOL using condition-specific measures in Turkish patients with head and neck cancer who underwent different oral rehabilitation modalities.22,23 To the best of our knowledge, there is no study evaluating the HRQOL of patients who had undergone maxillectomy and rehabilitated with obturator prostheses and the effect of prosthodontic therapy with obturator prostheses on their HRQOL. It is known that prosthetic obturator rehabilitation after maxillectomy is a positive and noninvasive approach to improve the oronasal functions, resocialization, and HRQOL of patients with maxillectomy defects.3,4,6,24 In these patients, impaired functioning and handling of the obturator may lead to difficulties with speech, mastication, and swallowing or facial disfigurement, thereby decreasing patient satisfaction.4,7 This is the first study to evaluate HRQOL using the OFS in Turkish patients rehabilitated with maxillary obturator prostheses after maxillectomy. We used the OFS for the evaluation of HRQOL because this function- and performance-specific questionnaire may be used to identify patients at risk for poor HRQOL and to determine patient satisfaction and unmet functional and social needs related to prosthetic rehabilitation.5,7,8,10,25 Bivariate analyses showed that patients with less than 8 years of schooling reported significantly better obturator functioning, less difficulty swallowing solid foods, lower dissatisfaction with noticeable clasps compared with those with 8 years or more of schooling, and older patients had more problems with insertion of their prostheses. These results may be explained by the fact that older patients had difficulty inserting prostheses because of reduced psychomotor skills, and patients with higher education level would be more concerned with their health and aware of their body image.26,27 However, some studies reported contradicting findings about the association between sociodemographic factors and obturator functioning. Gupta et al.11 found that obturator functioning was significantly related to educational status. Some researchers did not find any differences in obturator functioning in terms of age and gender,6,11 whereas Chen et al.18 reported that patients age 60 years and over reported more problems with swallowing solids and that women had lower appearance scores compared with men. In addition, Rieger et al.25 reported that women experienced greater changes in voice compared with men. Smoking and alcohol consumption were not associated
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ORIGINAL ARTICLE Ozdemir-Karatas et al. 5
Table II. Comparison of the OFS and its subscale scores according to sociodemographic, clinical and behavioral variables (n = 41) Variables Gender*
Male (n = 24) Female (n = 17)
Marital status*
Single (n = 7) Married (n = 34)
Employment status*
Employed (n = 15) Unemployed (n = 26)
Educational level*
≤8 years (n = 25) >8 years (n = 16)
Smoking after tumor treatment*
Yes (n = 6) No (n = 35
Alcohol after tumor treatment*
No (n = 33) Yes (n = 8)
Treatment type*
Surgery alone (n = 16) Surgery + radiotherapy (n = 25)
Surgery type*
Transoral (n = 33) Transfacial (n = 8)
Defect size*
Class ≤ 2b (n = 19) Class > 2b (n = 22)
Stage of disease*
Early stage (n = 26) Advanced (n = 15)
Dental condition in maxilla*
Dentate (n = 32) Edentate (n = 9)
Degree of resection*
HP (n = 29) HP + SP (n = 12)
Age (y), r Family monthly income, r
OFS total Mean ± SD
OFS eating Mean ± SD
OFS speech Mean ± SD
OFS other Mean ± SD
38.19 ± 21.48 35.49 ± 17.75 P = .822 39.52 ± 15.08 36.56 ± 30.83 P = .615 34.00 ± 19.64 38.84 ± 20.10 P = .408 31.60 ± 19.00 45.62 ± 18.52 P = .026 37.77 ± 20.18 36.95 ± 20.07 P = .868 37.17 ± 19.91 36.66 ± 20.85 P = .947 33.75 ± 21.32 39.20 ± 18.96 P = .429 32.22 ± 18.81 57.08 ± 7.85 P = .001 29.82 ± 21.18 43.33 ± 16.61 P = .021 34.10 ± 18.65 42.22 ± 21.40 P = .260 35.52 ± 20.73 42.59 ± 16.05 P = .305 34.25 ± 20.01 43.88 ± 18.41 P = .182 −0.177 0.134
40.97 ± 29.88 38.23 ± 30.48 P = .777 38.09 ± 36.91 40.19 ± 28.75 P = .916 32.22 ± 33.01 44.23 ± 27.46 P = .172 34.66 ± 26.75 47.91 ± 33.26 P = .177 44.44 ± 36.00 39.04 ± 29.13 P = .763 39.39 ± 29.40 41.66 ± 33.33 P = .933 37.50 ± 28.86 41.33 ± 30.85 P = .692 34.84 ± 30.72 60.41 ± 12.40 P = .011 35.08 ± 32.81 43.93 ± 26.99 P = .235 39.10 ± 24.46 41.11 ± 38.24 P = .989 37.50 ± 32.24 48.14 ± 17.56 P = .222 36.78 ± 29.33 4722 ± 30.84 P = .273 0.053 0.079
35.41 ± 23.95 35.88 ± 27.85 P = .947 41.42 ± 19.51 34.41 ± 26.42 P = .327 35.33 ± 24.16 35.76 ± 26.40 P = .967 29.20 ± 21.96 45.62 ± 27.56 P = .062 36.66 ± 21.60 35.42 ± 26.16 P = .766 35.75 ± 26.69 35.00 ± 20.00 P = .934 34.37 ± 28.74 36.40 ± 23.43 P = .666 32.42 ± 24.87 48.75 ± 24.16 P = .065 31.05 ± 26.85 39.54 ± 23.80 P = .200 31.92 ± 25.77 42.00 ± 23.96 P = .163 35.31 ± 25.90 36.66 ± 24.49 P = .787 30.34 ± 21.95 48.33 ± 29.18 P = .062 −0.073 0.082
38.98 ± 23.82 34.03 ± 16.07 P = .416 38.77 ± 16.42 36.55 ± 21.87 P = .930 33.80 ± 22.17 38.73 ± 20.32 P = .453 32.00 ± 22.12 44.64 ± 16.59 P = .058 35.71 ± 24.74 37.14 ± 20.55 P = .941 37.22 ± 20.41 35.71 ± 24.14 P = .765 31.69 ± 21.02 40.28 ± 20.50 P = .157 30.95 ± 18.35 61.60 ± 9.30 P = .000 26.69 ± 20.59 45.77 ± 17.02 P = .004 33.51 ± 19.45 42.85 ± 22.58 P = .177 34.82 ± 21.06 44.44 ± 19.48 P = .260 35.96 ± 22.54 39.28 ± 16.82 P = .058 −0.675 0.088
HP, hard palate; HP + SP, hard + soft palate; OFS, obturator functioning scale; r, spearman’s rank correlation coefficient; SD, standard deviation. *Statistical evaluation by Mann-Whitney U test.
Table III. Predictors of worse obturator functioning and satisfaction (n = 41) Best model (R2 = 0.340; F = 9.792; P < .001) Educational level† Surgery type†
β*
t
P value
0.297 0.470
2.241 3.544
.031 .001
*Standardized beta coefficients are presented. † Dichotomized variables: Gender (0, ≤8 years of schooling; 1, >8 years of schooling). Surgery type (0, transoral; 1, transfacial).
with overall functioning of and satisfaction with obturator prostheses in these patients. Clinical factors, such as soft palate resection, cancer stage, premorbid dentition, and postoperative radiation
therapy, were not associated with OFS total and subscale scores in this study. In contrast to our results, previous studies reported that postoperative radiation therapy,6,18,25 premorbid dentition,5,18 and degree of resection,10,25 were the most significant predictors of better obturator functioning in patients who had undergone maxillectomy and were rehabilitated with maxillary obturator prostheses. Earlier studies reported that the size of the maxillectomy10,27,28 and surgical approach8-10 were associated with oral functioning. Consistent with previous studies, we found that patients who underwent transfacial surgery reported significantly higher scores on the total OFS and the “eating” subscale compared with those who underwent transoral surgery.8-10 In addition, these patients had worse scores for 5 items (difficulty chewing
ARTICLE IN PRESS ORAL AND MAXILLOFACIAL SURGERY 6 Ozdemir-Karatas et al.
foods, leakage while swallowing, dissatisfaction with appearance, noticeable clasps on front teeth, and numb upper lip). This is not surprising because patients treated with transfacial surgery experience some specific functional and aesthetic problems because of scar formation and contracture in their upper lip.28 Our study patients with larger defect sizes had worse scores for overall obturator functioning and for 4 other items (xerostomia, nasal speech, clasps on front teeth, and numbness in upper lip) compared with those with smaller defects. Similar findings were reported by Kornblith et al.,10 who found that patients who had no more than one-third of the soft palate and one-fourth of the hard palate resected had better speech scores and overall obturator function. In the study by Chen et al.,18 patients with larger defects faced more problems with swallowing solids and nasal regurgitation of fluids or solids while eating or drinking. These difficulties may be caused by inadequate retention and stability of the prosthesis leading to worse functional outcomes and patient dissatisfaction. However, some contradictory findings have been reported regarding the influence of these clinical factors in patient satisfaction and obturator functioning.6,7,9 These contradictions may be attributed to the difference in study designs, sample sizes, and patient-related characteristics. The sample size in our study was lower than those in the studies conducted by Seignemartin et al., 28 Khan et al., 29 and Kornblith et al.10 The mean age of our patients was 52.48 ± 12.84 years. This finding is similar to those of the studies by Depprich et al.,7 Irish et al.,8 and Gupta et al.11 Compared with the patients in previous studies,2,10,25 our patients reported more problems with chewing, but less than those reported by Khan et al.29 The percentage of patients who had leakage while swallowing was also higher in our study compared with previous studies.10,25,29 Our patients reported fewer problems with voice change and dry mouth compared with those in previous studies.8,10,25,29 This may be related to the small number of patients in our study who had had soft palate resection. The number of patients who had nasal speech and who reported difficulty enunciating words was higher than those in previous studies.8,10,25,29 Our patients reported more difficulties with talking in public and avoiding family/social events compared with patients in previous studies.8,10,25,29 It should be noted that our patients experienced more difficulty inserting their obturators than that reported in previous studies. The differences between the results of earlier studies and this study may be attributed to the patient-related characteristics (e.g., clinical, psychological, and psychomotor factors and social and cultural beliefs). To the best of our knowledge, this was the first study using the OFS to determine the clinical and sociodemographic factors affecting the functioning of and patient
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satisfaction with obturators in Turkish patients who had undergone maxillectomy and were rehabilitated with obturator prostheses. The Turkish version of the OFS showed satisfactory internal consistency and test–retest reliability. However, our study had some limitations. The crosssectional design could not explain causation and changes over time in patient satisfaction and obturator functioning. The retrospective design of this study did not permit preoperative assessment of HRQOL. Future longitudinal studies using the OFS may provide valuable information for the maxillofacial prosthetic team in assessing self-perceived changes in the HRQOL of these patients. This study was conducted with a convenience sample of maxillectomy patients rehabilitated with conventional obturator prostheses at the Prosthodontics Clinic of our faculty, limiting the generalizability of the results and the conclusions. Maxillectomy patients who received free flap reconstruction and those who were rehabilitated with implant-supported obturator prostheses were not included in this study because of the small number of patients. Well-designed clinical studies are necessary to evaluate the impacts of different types of obturators and retention mechanisms on the functional quality of the obturator prosthesis and patient satisfaction. Earlier studies5-8,10,25 investigating the relationship between obturator functioning and psychological factors (i.e., psychological distress, anxiety, depression, and loss of behavioral control) have reported the importance of integrating psychological care into the treatment plan. In future studies, adding a generic HRQOL measure to the OFS may provide greater insight into the emotional and psychological needs of these patients because this information is important to clinicians in the development of a comprehensive treatment plan.8,10 Although there has been an increase in HRQOL studies, only a small number of studies has examined the influence of clinical and sociodemographic factors on patients’ HRQOL.11,18,29 To date, only 1 study, by Depprich et al., has evaluated the relationship between sociodemographic and behavioral factors and their impact on patients’ HRQOL.7 The strengths of this study include the wide range of sociodemographic and behavioral data as well as the use of a validated HRQOL.
CONCLUSIONS The results of our study indicate that the education level and surgery type were the most important predictors for worse obturator functioning and poor patient satisfaction in Turkish patients who had undergone maxillectomy. The Turkish version of the OFS may be a useful tool for clinicians to identify Turkish patients who are at risk for poor HRQOL and their unmet needs and to develop a comprehensive prosthodontic rehabilitation program. The authors wish to thank all the patients who participated in the study, and Dr. Didem Ozdemir-Ozenen and Dr. Elif
ARTICLE IN PRESS OOOO Volume ■■, Number ■■ Sungurtekin Ekci for their assistance with editing this manuscript. REFERENCES 1. Pace-Balzan A, Rogers SN. Dental rehabilitation after surgery for oral cancer. Curr Opin Otolaryngol Head Neck Surg. 2012;20: 109-113. 2. Lethaus B, Lie N, de Beer F, Kessler P, de Baat C, Verdonck HW. Surgical and prosthetic reconsiderations in patients with maxillectomy. J Oral Rehabil. 2010;37:138-142. 3. Salinas TJ. Prosthetic rehabilitation of defects of the head and neck. Semin Plast Surg. 2010;24:299-308. 4. Kumar P, Alvi HA, Rao J, et al. Assessment of the quality of life in maxillectomy patients: a longitudinal study. J Adv Prosthodont. 2013;5:29-35. 5. Riaz N, Warriach RA. Quality of life in patients with obturator prostheses. J Ayub Med Coll Abbottabad. 2010;22:121-125. 6. Chigurupati R, Aloor N, Salas R, Schmidt BL. Quality of life after maxillectomy and prosthetic obturator rehabilitation. J Oral Maxillofac Surg. 2013;71:1471-1478. 7. Depprich R, Naujoks C, Lind D, et al. Evaluation of the quality of life of patients with maxillofacial defects after prosthodontic therapy with obturator prostheses. Int J Oral Maxillofac Surg. 2011; 40:71-79. 8. Irish J, Sandhu N, Simpson C, et al. Quality of life in patients with maxillectomy prostheses. Head Neck. 2009;31:813-821. 9. Kreeft AM, Krap M, Wismeijer D, et al. Oral function after maxillectomy and reconstruction with an obturator. Int J Oral Maxillofac Surg. 2012;41:1387-1392. 10. Kornblith AB, Zlotolow IM, Gooen J, et al. Quality of life of maxillectomy patients using an obturator prosthesis. Head Neck. 1996;18:323-334. 11. Gupta R, Luthra RP, Gupta S. Evaluation of quality of life of maxillectomy patients after prosthetic obturator rehabilitation. Int Dent Med J Adv Res. 2016;2:1-4. 12. Cawood JI, Stoelinga PJ, International Academy for Oral and Facial Rehabilitation. International Academy for Oral and Facial Rehabilitation—consensus report. Int J Oral Maxillofac Surg. 2006; 35:195-198. 13. Kanatas AN, Rogers SN. A systematic review of patient selfcompleted questionnaires suitable for oral and maxillofacial surgery. Br J Oral Maxillofac Surg. 2010;48:579-590. 14. Murphy BA, Ridner S, Wells N, Dietrich M. Quality of life research in head and neck cancer: a review of the current state of the science. Crit Rev Oncol Hematol. 2007;62:251-267. 15. Beumer J, Curtis TA, Marunick MT. Maxillofacial Rehabilitation: Prosthodontic and Surgical Considerations. St. Louis, MO: Ishiyaku EuroAmerica Inc.; 1996:279. 16. Guillemin F, Bombardier C, Beaton D. Cross cultural adaptation of health-related quality of life measures: literature and proposed guidelines. J Clin Epidemiol. 1993;46:1417-1432. 17. Bonett DG. Sample size requirements for testing and estimating coefficient alpha. J Educ Behav Stat. 2002;27:335-340.
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Reprint requests: Meltem Ozdemir-Karatas, PhD, DDS Department of Prosthodontics Faculty of Dentistry Istanbul University Capa Istanbul Turkey [email protected].