Two wound-covering materials in the surgical treatment of oral submucous fibrosis: a clinical comparison

Two wound-covering materials in the surgical treatment of oral submucous fibrosis: a clinical comparison

Journal of Oral Biology and Craniofacial Research 2012 April Volume 2, Number 1; pp. 10–14 Original Article Two wound-covering materials in the surg...

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Journal of Oral Biology and Craniofacial Research 2012 April Volume 2, Number 1; pp. 10–14

Original Article

Two wound-covering materials in the surgical treatment of oral submucous fibrosis: a clinical comparison Harsha Pradhan1, Hemant Gupta2, VP Sinha3, Sumit Gupta4, MC Shashikanth5 1

Oral and Maxillofacial Surgeon, 2Professor and Head, Department of Oral and Maxillofacial Surgery, 3,4Reader, 5Professor and Head, Department of Oral Medicine, Diagnosis and Radiology, Babu Banarsi Das College of Dental Sciences, Lucknow, India.

ABSTRACT Introduction: Oral submucous fibrosis (OSMF), a chronic debilitating condition of the mouth, has been treated both surgically and non-surgically, but non-surgical methods yield inconsistent results. The surgical methods essentially comprise of bilateral sectioning of fibrous bands with or without coronoidectomy followed by covering of the surgical defect with a graft or a wound dressing material such as collagen sheet. Materials and Methods: This study comprised 30 clinically diagnosed cases of OSMF. This study compared transposition of buccal pad fat graft with collagen sheet to cover the defect within the following parameters: pain, swelling, mouth opening, color of mucosa, palpability of fibrous bands, and suppleness of mucosa. Results: We found significant difference in the postoperative mouth opening, an insignificant difference for post surgical morbidity and higher grades of surgical convenience in using collagen sheet as a wound dressing material. Conclusion: Collagen membrane is a superior method compared to transposition of the buccal pad of fat as a graft to cover the surgical wound in the treatment of OSMF of grade III and above. Keywords: Buccal fat pad, collagen sheet, oral precancer, oral submucous fibrosis.

INTRODUCTION

MATERIALS AND METHODS

Oral submucous fibrosis (OSMF), a chronic debilitating condition of the mouth, has been known since the times of Sushruta as Vidari.1 In recent times, its treatment includes non-surgical and surgical methods. The surgical treatment essentially comprises bilateral sectioning of fibrous bands with or without coronoidectomy besides the use of other modalities as nasolabial flaps,2,3 split skin grafts,4 transposition of the buccal pad of fat,5–9 dorsal tongue flap,9,10 radial forearm flaps,11 flaps of the temporalis fascia/muscle or both,10,12 palatal island flaps,7 and mucosal grafts,13 to cover the surgical defect. In this study, two modalities, the transposition of the buccal pad of fat5–9 (as a graft to cover the surgical wound) and the use of the collagen sheet11 as a wound dressing material, have been compared for the convenience of their use, mouth opening achieved, and postsurgical morbidity to the patient. This study was conducted to assess the feasibility of each wound-covering on the basis of clinical results and surgical convenience.

This study comprised 30 patients suffering from OSMF who attended the Outpatient Department of Oral and Maxillofacial Surgery, Babu Banarsi Das College of Dental Sciences. Diagnosis was made on the basis of clinical findings: decreased mouth opening, blanched oral mucosa, palpable fibrous bands, reduced mucosal suppleness, burning sensation in the oral mucosa. Patients suffering from chronic and debilitating disease (diabetes mellitus, pulmonary tuberculosis, etc.) were excluded from this study. Informed consent was obtained from all included patients. The study was ethically approved by the institutional review board. All patients were thoroughly examined and findings were recorded in a standardized format. Patients for surgery were selected irrespective of age, sex, religion, or socio-economic status. Irrespective of treatment modality, all patients were counseled to quit all deleterious habits. These patients were randomly divided into two equal groups of 15 patients each. Group I: after sectioning of fibrous bands, a dry collagen sheet was placed over the mucosal

Correspondence: Dr. Harsha Pradhan, E-mail: [email protected] doi: 10.1016/S2212-4268(12)60004-9

Two wound-covering materials in surgical treatment of OSMF: comparison

defect and sutured as a surgical dressing, group II: after incising of buccal fibrous bands, the buccal fat pad was mobilized to cover the entire mucosal defect and sutured to the entire length of the mucosal defect. Surgery was performed under local anesthesia. A longitudinal incision was placed on the buccal mucosa bilaterally, avoiding injury to Stenson’s duct, extending from the third molar region to just posterior to the commissure of the mouth (Figure 1). Blunt dissection and sectioning of fibrous bands were then done. Collagen sheets or buccal pad of the fat was used to cover the defect (Figures 2–6). Povidone iodine mouthwash as an oral rinse 3–4 times daily, and postoperative physiotherapy was advised. Details were recorded for pain using a visual analogue scale (VAS) scored on a scale of 1–10, swelling, mouth opening (mm), color of the mucosa, palpability of fibrous bands, suppleness of the mucosa, and surgical convenience. All patients were followed for a period of 42 days. Convenience of carrying out the surgery was assessed using three grades 1–3; 1 as the least convenient and 3 as the most convenient.

RESULTS Demographically, the groups were matched for age and gender (P > 0.05). No significant difference between the two groups was observed for pain and swelling. Mean mouth opening at day 42 in group II was significantly higher as compared with that in group I (P = 0.050) (Tables 1 and 2). A significant difference between the two groups was observed for the median grade for surgical convenience (P < 0.001). The median grade for surgical convenience in group I was 2 whereas in group II it was 3.

DISCUSSION All proponents of surgical treatment of OSMF have mentioned the sectioning of fibrous bands bilaterally with or without coronoidectomy. Although various authors have proposed different graft/dressing materials for wound coverage, we restricted ourselves to two modalities; collagen sheet as a wound dressing material to cover the surgical defect and the buccal pad of fat rotated onto the defect as a graft to cover it. We believed that they are relatively convenient and carry less postoperative morbidity. Fat transplantation has been known since 1892 when Newber first described it.5 However, it has been a controversial subject.5 The first report of the use of the buccal pad

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of fat as a pedicled graft for defects up to 4 cm in diameter covering it with a free-split thickness skin graft was made in 1977.6 The use of the buccal pad of fat for reconstruction in oral defects was studied to evaluate its feasibility as a flap for the reconstruction of oral defects, comparison with the buccal flap and to determine suitable sites for its use. It was found that harvesting of the buccal pad of fat did not produce any marked defect in the cheek.8 In reference to the oral cavity, buccal fat pad is a technically easy procedure, both donor and recipient sites are contiguous in the oral cavity, there is no visible scar in the donor area, the problem of losing transplanted fatty tissue in the long-term is a negligible factor as the anatomic proximity of the donor and recipient sites permits rapid grafting without having the fatty graft too long outside the body of the patient.5 Also, the fat pad graft was directly rotated onto the defect, it was not necessary to sever the graft pedicle.7 The uncovered pedicled graft provided a bed of tissue for subsequent epithelization thereby obviating the need of split thickness skin cover. In our study, it was proposed to rotate the buccal pad of fat onto the defect on its pedicle, as pedicled graft provides a bed of tissue for subsequent epithelization, and we chose not to cover the graft. Some authors believed that histiocytes replaced all fatty transplanted tissue after taking on lipid from broken fatty cells.4 Others believed in the cell survival theory.14,15 The advantages of collagen sheet as a wound dressing material in OSMF surgery include the easy availability of collagen sheet, convenience of application, good tolerance of oral tissue, no adverse effects of the use of this membrane, obviation of second surgery to obtain graft or detachment of the pedicle, there is no morbidity associated with the use of grafts, and there are no problems associated with donor site healing.11 In our study, the two surgeries were carried out with the intention of assessing their relative efficacy. Like any other surgical treatment, these methods also entail postoperative discomfort/morbidity, which cannot be overlooked while finding the efficacy of a particular treatment. It is with the above consideration that subjective parameters like pain, swelling, color of the mucosa, palpability of fibrous bands and suppleness of the mucosa were included in this study; these coupled with postoperative mouth opening, at the end of the follow-up period, would constitute the efficacy of one over the other. Our results showed that a significantly higher proportion of the group II surgeries had lower grades of surgical convenience implying that the use of the collagen sheet is a more convenient procedure to execute. The explanation for the same is based on the facts that the collagen sheet does not need deep dissection as mobilization of the buccal pad of fat for transposition is not required and has fewer complications,10 less difficulties, and a shorter operating time.

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Pradhan et al.

Table 1 Groupwise comparison of demographic and clinical parameters Characteristics Demographic characteristics Mean age ± SD (range) (yr) Male:female Postoperative assessment Postoperative pain Day 1 (baseline) Day 2 Day 3 Day 5 Day 7 Day 14 Day 28 Day 42 Postoperative swelling Day 1 (baseline) Day 2 Day 3 Day 5 Day 7 Day 14 Day 28 Day 42 Postoperative mouth opening Pre-operative (baseline) Day 1 Day 2 Day 3 Day 5 Day 7 Day 14 Day 28 Day 42

Group I (n = 15)

Group II (n = 15)

Significance

33.27 ± 14.57 (18–65) 13:2

39.40 ± 14.86 (18–65) 12:3

z = 1.079; P = 0.285 χ2 = 0.240; P = 0.624

2.27 ± 0.70 1.87 ± 0.64* 1.73 ± 0.59* 1.7 ± 0.88** 0.20 ± 0.56** 0.7 ± 0.26*** 0.7 ± 0.26*** 0*** 0 1.87 ± 0.52 1.60 ± 0.83* 1.33 ± 0.82* 0.73 ± 0.70*** 0.20 ± 0.41*** 0*** 0*** 0*** 17.67 ± 3.58 16.33 ± 3.83* 17.13 ± 4.10 18. ± 4.21 19.67 ± 3.83** 22.13 ± 4.9** 27.53 ± 4.90** 32.7 ± 5.5** 36.53 ± 5.96**

2.07 ± 0.46 1.80 ± 0.68* 1.33 ± 0.72** 1 ± 0.54** 0.27 ± 0.46*** 0*** 0*** 0***

z = 1.046; P = 0.389 z = 0.050; P = 0.967 z = 1.438; P = 0.202 z = 0.047; P = 0.967 z = 0.775; P = 0.595 z = 1.000; P = 0.775 z = 1.000; P = 0.775 z = 0; P = 1

2.47 ± 0.52 2.20 ± 0.41* 1.60 ± 0.63** 0.87 ± 0.74*** 0.53 ± 0.83*** 0.13 ± 0.35*** 0*** 0***

z = 2.773; P = 0.016 z = 2.308; P = 0.061 z = 0.662; P = 0.567 z = 0.496; P = 0.653 z = 1.044; P = 0.0.436 z = 1.439; P = 0.539 z = 0; P = 1 z = 0; P = 11

17.47 ± 4.49 16.13 ± 4.22** 16.60 ± 4.10* 17.33 ± 4.47 18.87 ± 4.82 20.60 ± 5.1** 26.67 ± 4.24** 33.33 ± 4.19** 39.87 ± 2.85**

z = 0.209; P = 0.838 z = 0.251; P = 0.806 z = 0.794; P = 0.436 z = 0.520; P = 0.624 z = 0.605; P = 0.567 z = 0.937; P = 0.367 z = 0.710; P = 0.486 z = 0.565; P = 0.595 z = 1.997; P = 0.050#

*P < 0.05; **P < 0.01; ***P < 0.001 as compared to baseline; #borderline significant. SD = standard deviation.

Table 2 Groupwise comparison of outcome features Characteristics

Group I (n = 15)

Group II (n = 15)

Significance

5 5 II 0 6 (40%)

5 5 III 0 12 (80%)

z = 0.850; P = 0.595 z = 1.100; P = 0.305 z = 3.949; P < 0.001 Fisher exact P = 1 Fisher exact P = 0.060

Median time taken for complete resolution of pain Median time taken for complete resolution of swelling Median grade for surgical convenience Suppleness of mucosa Restoration of normal color of mucosa by day 42

Postoperative pain was controlled in all patients using the same analgesic of the same dosage, frequency, and prescribed for the same length of time. Postoperative pain was assessed on a VAS scale of 0–10. By postoperative day 14,

with the exception of one patient in group I, no patient of either group had even mild pain. This pattern of decline of pain along with the progression of time is indicative of proper healing in both the groups. The patient who complained of

Two wound-covering materials in surgical treatment of OSMF: comparison

Figure 1 Incision.

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Figure 4 Collagen sheet sutured in place (immediate postoperative).

Figure 2 Mobilization of buccal pad of fat. Figure 5 Collagen sheet in place (late postoperative).

Figure 3 Buccal pad of fat sutured in place.

pain was an unco-operative lady who had stopped taking prescribed drugs before the end of the prescribed time, consulted her own physician from day 2 onwards, changed the medication schedule, and did not carry out the postoperative physiotherapy. Hence, the conclusion that the group I procedure is inferior cannot be reached. Swelling subsided by day 14 in all patients in group I, whereas in group II two patients still had mild swelling.

Figure 6 Colagen sheet (dry).

It was only at the 28th day that no patient in group II had any swelling. This can be attributed to the fact that the use of the buccal pad of fat entails more morbidity at the surgical site (since the transposition of the buccal pad of fat requires deeper dissection and the pad must be mobilized adequately to cover the defect).

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Mouth opening in both groups, on postoperative day 1, showed a significant reduction as compared with the recorded immediate postoperative mouth opening. We attribute this reduction to postoperative pain and swelling due to which patients were not able to open their mouths fully. However, at the end of follow-up, there was a significant increase in mouth opening in both groups as compared with immediate postoperative mouth opening. Postoperative day 2 onward, mouth opening increased steadily from the pre-operative mouth opening to a mean of 36.53 in group I and 39.87 in group II at the end of follow-up. This observation suggests a successful outcome in both groups, and this result finds support of the various workers who recommend surgical resection of fibrous bands.1–4,8,9,12,16 Mouth opening was significantly higher in group II patients. Color of the mucosa was pale by day 28 in group I in all patients. At the end of follow-up period, six patients had a normal pale pink mucosa and nine patients had a pale mucosa in group I. In group II by day 28, no patient had opaque mucosa and one patient’s mucosa had returned to normal pale pink. At the end of follow-up period, in group II, 12 patients’ mucosa had returned to normal pale pink but 3 patients still had a pale mucosa. These results point to the slow return of the color of the mucosa to normal since this return is dependent on epithelization. Also, the faster return of normal color of mucosa in group II can be explained by the fact that the wound was covered by an autogenous graft in contrast to a collagen sheet dressing in group I. Palpability of fibrous bands pre-operatively was seen in all patients. Since these bands were sectioned during surgery, no patient had palpable buccal fibrous bands in postoperative follow-up period. Suppleness of the mucosa was noticed in group I and not in group II in early postoperative period. We have not been able to explain why on postoperative day 1 itself, more patients in group II still had a stiff mucosa (statistically significant difference). This difference continued till day 14 implying that the collagen sheet provided better suppleness of the mucosa at shorter intervals of time. Even after day 14, the proportion of patients with slightly supple mucosa was higher in group I (statistically significant). This difference ended only at the end of the follow-up.

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both procedures resulted in near normal mouth opening. Considering postoperative morbidity and surgical convenience, the use of a collagen sheet is a superior method to transposition of the buccal pad of fat.

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It was concluded that the use of collagen sheet, as a wound dressing material for the surgical treatment of OSMF, was more convenient than the use of the buccal pad of fat. There was a significant difference in mouth opening at the end of the follow-up period between the two groups although

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