A Randomized Clinical Trial of the Effects of Submucosal Dexamethasone After Surgery for Mandibular Fractures

CRANIOMAXILLOFACIAL TRAUMA

A Randomized Clinical Trial of the Effects of Submucosal Dexamethasone After Surgery for Mandibular Fractures Ashok Dongol, MDS,* Mehul Rajesh Jaisani, MDS,y Leeza Pradhan, MDS,z Sanad Dulal, MDS,x and Alok Sagtani, MDSk Purpose:

To evaluate the effects of immediate postoperative submucosal dexamethasone administration on postoperative pain, edema, trismus, and mandibular functions after open reduction and internal fixation (ORIF) for mandibular fractures.

Patients and Methods:

We conducted a prospective, randomized, controlled, double-blind study of 40 patients who required ORIF for mandibular fractures under general anesthesia. The patients were divided into 2 groups, an experimental group (n = 20) who received immediate postoperative submucosal 8 mg of dexamethasone through the surgical incision site, and a control group (n = 20) who did not receive dexamethasone. Pain was assessed using a visual analog scale (VAS) score and the frequency of analgesic consumption at the various postoperative intervals. The maximum interincisal distance and facial measurements were compared before surgery and at 24, 48, and 72 hours and 7 days after surgery. The difficulty in mandibular function after surgery was graded as mild, moderate, or severe.

Results:

The analgesic drugs required 2 hours after surgery and the VAS score 72 hours after surgery were significantly less (P < .05) in the experimental group than in the control group. The total number of diclofenac tablets required by the experimental group was less than that for the control group, but the difference was not statistically significant. The control group had significantly increased swelling (P < .05) compared with the experimental group from preoperatively to 24 hours postoperatively (experimental group 0.115  0.143, control group 0.253  0.173). No statistically significant difference was present in the mouth opening or difficulty in mandibular function at the different follow-up intervals between the 2 groups (P > .05).

Conclusion:

The results of our study suggest that submucosal administration of dexamethasone after ORIF for mandibular fractures is effective in reducing postoperative pain and edema. Ó 2015 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg -:1-9, 2015

The mandible is a commonly fractured bone in the face, a fact related to its prominent and exposed position. Open reduction and internal fixation (ORIF) of mandibular fractures has been associated with trauma to the surgical site and the surrounding tissues. Tissue trauma leads to increased inflammation in the perioperative area, with the release of large quantities of histamines, bradykinins, serotonins, and other substances.1 The inflammatory process occurs during healing; however,

extensive inflammation can cause the patient unnecessary pain, edema, trismus, and associated loss of function. Steroids are known to prevent inflammation by interfering with capillary dilatation, edema formation, fibrin deposition, leukocyte migration, and phagocytosis. Among the available steroids, dexamethasone has the greatest anti-inflammatory activity, no mineralocorticoid activity, and a biologic half-life of 36 to 54 hours, the longest available.2 The submucosal

Received from Department of Oral and Maxillofacial Surgery, BP

of Health Sciences, Buddha Chowk, Dharan 56700, Nepal; e-mail:

Koirala Institute of Health Sciences, Dharan, Nepal.

[email protected]

*Assistant Professor. yAssociate Professor and Head of Department.

Received November 19 2014 Accepted December 31 2014

zAssistant Professor.

Ó 2015 American Association of Oral and Maxillofacial Surgeons

xFormer Resident.

0278-2391/15/00025-7

kAdditional Professor.

http://dx.doi.org/10.1016/j.joms.2014.12.042

Address correspondence and reprint requests to Dr Dongol: Department of Oral and Maxillofacial Surgery, BP Koirala Institute

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EFFECTS OF SUBMUCOSAL DEXAMETHASONE AFTER MANDIBULAR FRACTURE SURGERY

administration route is used to inject the drug in the vicinity of the surgical site. Several studies have been conducted on the use of submucosal dexamethasone after maxillofacial surgeries such as third molar extraction3-8 and apicectomy.9 These studies suggested that submucosal dexamethasone significantly reduces postoperative pain, edema, trismus, and discomfort. The present study evaluated the effects of submucosal administration of a single dose of 8 mg of dexamethasone on postoperative pain, edema, trismus, and mandibular function after ORIF for mandibular fractures.

Materials and Methods We performed a prospective, randomized, controlled, double-blind study of patients aged 15 to 55 years who required ORIF for mandibular fractures under general anesthesia to determine the effects of postoperative submucosal dexamethasone. All the patients provided informed written consent regarding the study and photographs. The present study was performed in accordance with the guidelines of the Declaration of Helsinki and the institutional ethical review board of BP Koirala Institute of Health Sciences (Dharan, Nepal) provided ethical approval. Patients with existing gastrointestinal ulceration, Cushing syndrome, severe forms of heart insufficiency, severe hypertension, uncontrolled diabetes mellitus, systemic tuberculosis, severe systemic viral, bacterial, and fungal infections, pre-existing wide-angle glaucoma, osteoporosis, psychiatric diseases, pregnancy, renal failure, a history of systemic steroid administration, allergy to any of the components of the trial drug preparation, other associated injuries, or an inability to comprehend pain were excluded. A total of 40 patients were enrolled in the present study. Randomization was performed using computer-generated codes. The patients were divided into 2 groups of 20 patients each. The experimental group received immediate postoperative submucosal infiltration of 8 mg dexamethasone in the vicinity of the surgical site, and the control group did not. Both the groups received intravenous ampicillin + cloxacillin 1 g and metronidazole 500 mg as antibiotics before and after surgery. The demographic data and baseline characteristics were obtained to ensure group comparability. The fracture site, interval between trauma and surgery, and operative duration were recorded. SURGERY

All the patients in the present study underwent surgery using a standard technique under general anesthesia by the same operator who was kept unaware of the study details. Exposure of the fractured fragments was performed using an intraoral approach with a vestibular incision or an extraoral approach through the pre-existing laceration. The patients were

kept unaware of their group. ORIF was performed as per the fracture site of mandible. Fractures of the condyle, when present with other mandibular fractures, were managed conservatively. After closure of the incision site, the experimental group received 8 mg of dexamethasone as a submucosal infiltration in the surgical incision site and the control group did not. In cases of multiple fractures, 8 mg of dexamethasone was divided and administered at multiple fracture sites. The duration of surgery was recorded. MEASUREMENTS

All measurements were performed by a single observer who was unaware of the administration of the medication. Edema and mouth opening were measured preoperatively and 24, 48, and 72 hours and 7 days after surgery. Edema was assessed as a mean of a 9-line measurement10 using a plastic measuring tape (line 1, right gonion to right lateral canthus of eye; line 2, left gonion to left lateral canthus; line 3, right tragus to right commissure of lip; line 4, left tragus to left commissure of the lip; line 5, right tragus to midline in chin; line 6, left tragus to midline in chin; line 7, right tragus to right ala; line 8, left tragus to left ala; and line 9, right gonion to left gonion) as shown in Figure 1. The mouth opening was measured as the maximum interincisal distance using a Vernier caliper. Pain was measured using a 10-cm visual analog (VAS) scale, consisting of a 10-cm horizontal line labeled ‘ No pain’’ at one end and ‘ Worst pain ever’’ at the other end. The intensity of pain was assessed by asking the patient to indicate on the 10-cm line at the point that corresponded to the level of pain intensity experienced after 2, 4, 8, 12, 24, 48, and 72 hours and 7 days of ORIF. The distance in centimeters from the no pain end of the VAS to the patient’s mark was used as a numeric index of the severity of pain. If the pain intensity (VAS score) exceeded more than 5 (of 10), the patient received an injection of diclofenac 75 mg intramuscularly during the nothing by mouth period or a 50-mg diclofenac tablet when oral consumption was allowed. If the pain intensity (VAS score) exceeded more than 5 (of 10) even after 50 mg of oral diclofenac, an injection of diclofenac 75 mg intramuscularly was given as a rescue analgesic. Similarly, analgesic usage required 2, 4, 8, 12, 24, 48, and 72 hours and 7 days after ORIF was recorded. Difficulty in mandibular function (eg, mandibular movements, speech, swallowing, and mastication) was evaluated 24, 48, and 72 hours and 7 days after ORIF using grading scale of mild, moderate, and severe difficulty. STATISTICAL ANALYSIS

The collected data were edited and entered in a Microsoft Excel 2007 worksheet and converted to Statistical Package for Social Sciences, version 11.5 (IBM

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DONGOL ET AL

FIGURE 1. Lines of edema measurement. Red indicates gonion to lateral canthus of eye (right and left); black, tragus to commissure of lip (right and left); green, tragus to midline in the chin (right and left); blue, tragus to ala (right and left); and yellow, gonion to gonion. Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

Corp., Armonk, NY), for statistical analysis. For descriptive statistics, the mean, standard deviation, and percentage were calculated. The distribution of all the numeric variables was checked. The variables that did not follow a normal distribution were analyzed using a nonparametric test, the Mann-Whitney U test. The normally distributed variables were analyzed using an independent samples t test and paired t test. The measurement of the association of categorical variables was performed using a c2 test, and the odds ratio and 95% confidence interval were calculated.

Results No significant difference was found in the percentage of distribution between the experimental and control groups (P > .05) regarding the gender ratio and age. Both groups were comparable with respect to the interval between the trauma and surgery and duration of surgery (P > .05; Table 1). The cause of the

mandible fracture was a road traffic accident for 28 patients (70%), an injury from a fall for 8 (20%), physical assault for 3 (7.5%), and a sports-related injury for 1 patient (2.5%). An isolated parasymphysis fracture was present in 10 patients (25%) and was the most frequent; a parasymphysis with condyle fracture occurred in 8 patients (20%) and was also more frequent than that of other types. The fracture sites were almost equally distributed in the 2 groups (Table 2). A comparison of the edema from preoperatively to 24 hours postoperatively showed significant differences (P < .05) between the experimental and control groups. The control group had significantly increased swelling from preoperatively to 24 hours postoperatively (control group 0.253  0.173, experimental group 0.115  0.143; (Table 3, Fig 2)). Maximum edema was present at 24 hours postoperatively in both groups (control group 14.382  0.529, experimental group 13.963  0.886). No significant difference was

Table 1. COMPARISON OF SOCIODEMOGRAPHIC CHARACTERISTICS BETWEEN THE EXPERIMENTAL AND CONTROL GROUPS

Variable

Control Group

Experimental Group

Gender Male Female Age (yr) Interval between trauma and surgery (d) Operative duration (min)

18 (54.5) 2 (28.6) 27.75  10.39 5.60  1.09 74.50  16.29

15 (45.5) 5 (71.4) 27.85  8.82 5.60  3.45 67.00  21.60

Test

P Value

OR = 0.333

.407

t = 0.033 t < 0.001 t = 1.23

.974 1.000 .223

Data presented as mean  standard deviation or n (%). Abbreviation: OR, odds ratio. Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

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EFFECTS OF SUBMUCOSAL DEXAMETHASONE AFTER MANDIBULAR FRACTURE SURGERY

Table 2. FREQUENCY OF SITE OF MANDIBULAR FRACTURE BETWEEN THE EXPERIMENTAL AND CONTROL GROUPS

Site of Mandibular Fracture

Experimental Group

Control Group

5 3 1 1

5 2 1 0

4 2 2 1 1 0 0

4 2 1 2 1 1 1

Isolated fracture Parasymphysis Body Symphysis Angle Multiple fractures Parasymphysis and condyle Bilateral parasymphysis Parasymphysis and angle Angle and body Symphysis and condyle Angle and condyle Angle and symphysis

Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

observed regarding the measurement of edema from preoperatively to the other measurement intervals between the 2 groups. The VAS score 72 hours after surgery was significantly less (P < .05) in the experimental group (median 0, interquartile range [IQR] 0 to 1) than in the control group (median 2, IQR 1 to 2). No significant difference in the VAS score was present between the 2 groups at the other postoperative intervals (Table 4). The amount of analgesic required at 2 hours after surgery was significantly less for the experimental group than for the control group. However, no statistically significant difference was observed regarding the number of analgesics required between the groups at the other postoperative intervals. The number of diclofenac tablets required from 3 to 7 days was less for the experimental group (median 2.5, IQR 0.5 to 6.25) than for the control

group (median 4, IQR 2 to 8). Similarly, the total number of analgesic drugs required for experimental group (median 6.5, IQR 4.75 to 10) was less than that for the control group (median 8, IQR 6.5-15), but the difference was not statistically significant (Table 5). No significant differences were found between the groups in the limitation of mouth opening between the preoperative measurements and those at 24, 48, and 72 hours and 7 days postoperatively (Table 6). No statistically significant difference was observed between the 2 groups regarding the difficulty in mandibular function such as mandibular movement, speech, swallowing, and mastication. Difficulty in mandibular movement, speech, and swallowing was mild at 7 days postoperatively. Two patients in the experimental group developed an infection during their follow-up period. Fever was present in 2 patients in the control group and 4 in the experimental group during the hospital stay. No significant difference was found between the experimental and control groups (P > .05) regarding the incidence of postoperative infection or fever (Table 7).

Discussion ORIF is a surgical treatment modality for mandibular fractures that has been associated with pain, trismus, swelling, and postoperative morbidity that negatively affects a patient’s quality of life.11 The various factors that influence the healing process and associated inflammatory complications after ORIF for mandibular fractures include patient age, gender, and medical status, alcohol and substance abuse,12 the use of antibiotics,13 the fracture site, the interval between the trauma and surgery, the incision type, operating time,14 surgeon experience, fracture severity, and fixation methods used.15 In the present study, all the patients underwent ORIF by a single surgeon who was unaware of the study details. No significant variation was found in patient age, gender ratio, use of

Table 3. COMPARISON OF EDEMA PREOPERATIVELY AND AT DIFFERENT POSTOPERATIVE INTERVALS BETWEEN CONTROL AND EXPERIMENTAL GROUPS

Measurement Point Preoperative to 24 h postoperative Preoperative to 48 h postoperative Preoperative to 72 h postoperative Preoperative to 7 days postoperative

Group

Mean Difference In Edema

Control Experimental Control Experimental Control Experimental Control Experimental

0.253  0.173 0.114  0.143 0.182  0.164 0.113  0.153 0.031  0.228 0.0461  0.114 0.080  0.093 0.059  0.133

t Test Value

P Value

2.763

.009

1.380

.176

0.252

.802

0.579

.566

Data presented as mean  standard deviation. Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

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DONGOL ET AL

FIGURE 2. Comparison of mean edema between the 2 groups at different postoperative intervals. The control group experienced significantly increased swelling from preoperatively to 24 hours postoperatively compared with the experimental group, with no significant difference observed between preoperatively and the other postoperative intervals between the 2 groups. Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

antibiotics, interval between the trauma and surgery, or operative time between the 2 groups in the study; thus, all these variables were equally distributed in the 2 groups. Because fracture severity can affect the outcomes of the study, patients with comminuted, infected fractures were excluded from the present study. However, multiple fractures of the mandible were included in the study owing to the limited duration of the thesis study period. The occurrence of multiple fractures was

almost equally distributed between the 2 groups: 12 in the control group and 10 in the experimental group, with no statistically significant influence on the results. Submucosal administration of dexamethasone immediately in the postoperative period significantly reduced the incidence of swelling at the point of maximum edema in our study. Consistent with the findings from other studies of third molar extraction3-8 and apicectomy,9 submucosal dexamethasone significantly

Table 4. COMPARISON OF VISUAL ANALOG SCALE SCORE BETWEEN EXPERIMENTAL AND CONTROL GROUP AT DIFFERENT POSTOPERATIVE INTERVALS

Measurement Point VAS at 2 h VAS at 4 h VAS at 8 h VAS at 12 h VAS at 24 h VAS at 48 h VAS at 72 h VAS at 7 days

Group

VAS Score

Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental

3.5 (1-5) 4 (0.50-5.75) 2 (0-4) 2.5 (0-4) 1 (0-3) 1.5 (0-4) 1 (0-4) 1 (0-3) 2.5 (1-4) 2 (0.25-4) 1.5 (0-3) 1 (1-2) 2 (1-2) 0 (0-1) 0 (0-1) 0 (0-1)

Mann-Whitney U Statistic

P Value

192

.826

186

.699

172

.435

171.5

0.423

184.5

.670

194

.867

108.5

.010*

184

.610

Data presented as median (interquartile range). Abbreviation: VAS, visual analog scale. * Statistically significant. Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

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EFFECTS OF SUBMUCOSAL DEXAMETHASONE AFTER MANDIBULAR FRACTURE SURGERY

Table 5. COMPARISON OF NUMBER OF ANALGESICS REQUIRED BY CONTROL AND EXPERIMENTAL GROUPS AT DIFFERENT INTERVALS

Postoperative Interval 2h 4h 8h 12 h 24 h 48 h 72 h 72 h to 7 days Total required

Group

Analgesic (n)

Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental Control Experimental

1 (1-1) 1 (0.25-1) 0 (0-0) 0 (0-0) 0 (0-0) 0 (0-0) 0 (0-0) 0 (0-0) 1 (0-1.75) 1 (0.25-2) 2 (1.25-2) 1 (1-2) 0.5 (0-2) 1 (0-1.75) 4 (2-8) 2.5 (0.5-6.25) 8 (6.5-15) 6.5 (4.75-10)

Mann-Whitney U Statistic

P Value

150

.018

190

.317

190

.553

200

1.000

166

.332

163

.279

184

.644

146

.139

162.5

.306

Data presented as median (interquartile range). Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

reduced the severity of edema in our study. Steroids are known to suppress inflammatory mediators, which reduce capillary permeability, resulting less transudation of fluid and, thus, less edema. In contrast to our finding, maximum swelling was observed 48 hours after surgery in the study by Rana et al16 in patients who had undergone ORIF for bilateral mandibular fractures and in the study by Ristow et al17 who evaluated postoperative swelling, pain, and trismus after ORIF for mandibular fractures. The difference observed was more likely related to the shorter duration of surgery in our study (71 minutes) compared with their study (98 minutes), further supporting the affect of the operative time on the severity of postoperative edema. The pre-

cise duration of the edema response to oral surgery has not been well documented and probably varies from patient to patient and procedure to procedure. Laskin18 stated that edema will maximize within 24 to 48 hours; however, Peterson19 stated that it will usually maximize within 48 to 72 hours, resolving after the first postoperative week. However, additional studies are required to correlate the duration of surgery with the maximum edema period postoperatively. Although not statistically significant, the mean measurements of edema 24, 48, and 72 hours after surgery showed a more rapid tendency to decrease in the experimental group compared with the control group in our study. A prospective study with a greater sample size is

Table 6. COMPARISON OF MOUTH OPENING FROM PREOPERATIVELY TO POSTOPERATIVE INTERVALS BETWEEN CONTROL AND EXPERIMENTAL GROUPS

Interval Preoperatively to 24 h postoperatively Preoperatively to 48 h postoperatively Preoperatively to 72 h postoperatively Preoperatively to 7 days postoperatively

Group

Mouth Opening (mm)

t Test

P Value

Control Experimental Control Experimental Control Experimental Control Experimental

5.80  6.47 3.55  6.48 3.60  5.00 0.85  7.949 1.85  5.06 1.05  8.121 3.60  4.418 6.40  7.66

1.098

.279

1.309

.198

1.355

.183

1.416

.165

Data presented as mean  standard deviation. Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

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Table 7. PERCENTAGE OF DISTRIBUTION AND ODDS RATIO FOR POSTOPERATIVE COMPLICATIONS BETWEEN THE EXPERIMENTAL AND CONTROL GROUPS

Postoperative Complications Infection Absent Present Fever Absent Present

Control Group

Experimental Group

20 (52.6) 0 (0.0)

18 (47.4) 2 (100.0)

18 (52.9) 2 (33.3)

16 (47.1) 4 (66.7)

Odds Ratio

P Value

0.474

.487

2.250

.661

Data presented as n (%). Dongol et al. Effects of Submucosal Dexamethasone After Mandibular Fracture Surgery. J Oral Maxillofac Surg 2015.

required to definitely comment on that stated trend in the reduction of postoperative edema. In addition, including anthropometric points of measurements in the face that do not swell after ORIF for a fracture of a specific site might have masked the overall measurement of edema in our study. Additionally, edema is difficult to quantify accurately. Various methods such as the 3-dimensional optical scanner,16 facial plethysmography,20 photography,21,22 Holland’s facial bow technique,23 computed tomography,24 magnetic resonance imaging25 might have been better than the economic use of a measuring tape and the facial anatomic landmarks. Consistent with other studies3,5 conducted in third molar surgery, submucosal injection of dexamethasone resulted in encouraging pain reduction in our study. The lesser requirement of the first diclofenac injection within the first 2 hours after surgery within the steroid group can be attributed to the greater concentration of dexamethasone achieved immediately at the site of tissue injury through the submucosal route, where it suppressed the inflammatory mediators such as prostaglandin and bradykinin, which are known to reduce the pain threshold. The greater effective drug concentration can be achieved with the submucosal route because the loss in the distribution of the drug volume is limited, with less systemic absorption consistent with the concept of a local drug delivery system.4 Thus, this finding justifies the administration of immediate postoperative submucosal dexamethasone injection after ORIF for mandibular fractures for postoperative pain control. The significant pain reduction 72 hours after surgery in the steroid group in our study can be related to the cumulative neuromodulatory effects of dexamethasone and nonsteroidal antiinflammatory drugs, such as diclofenac, during the postoperative period to relieve pain in our study. Skjelbred and Lokken26 suggested that corticosteroids should be the drugs of choice for preventing edema; however, nonsteroidal anti-inflammatory drugs could be required for better pain relief. Although some reduction in post-

operative pain will generally accompany a reduction of edema, studies have suggested that steroids alone will not have a clinically significant analgesic effect.4,5,27 The findings from our study justify the concomitant use of submucosal administration of dexamethasone and systemic administration of nonsteroidal antiinflammatory drugs26,28,29 in reducing postoperative pain after ORIF for a mandibular fracture. Submucosal dexamethasone does not have any direct influence on muscle contraction to cause a decrease in trismus.4 A search of the published data revealed studies with findings suggestive of less trismus with the use of steroids, although the differences were not statistically significant.4,10,26,27,30-32 A decrease in trismus can be secondarily related to a lesser degree of local inflammation.5 Additional research is needed with a larger sample size to establish the effect of submucosal dexamethasone in reducing postoperative trismus, such as has been well documented in previous studies3,6-8 after third molar extraction. Mandibular movement, speech, swallowing, and mastication were evaluated using a grading scale of mild, moderate, and severe in the present study. It has been found that surgeon-rated scores or objective testing will be significantly different than the patient’s perspective.33 Patient self-completed questionnaires are the most reliable method by which patientcentered outcomes can be measured.34 In a study by Grossi et al,4 evaluation of postoperative symptom severity was performed with the help of questionnaires designed to assess the postoperative discomfort using 7 subscales—eating, speech, sensation, appearance, pain, sickness, and interference with daily activities. A significant result in appearance was observed with the use of steroids that they correlated with edema. Similarly, in the study by Majid,3 who assessed patients’ quality of life after third molar surgery using a questionnaire, the dexamethasone groups showed a highly significant difference in the effect on patients’ quality of life in all subscale scores (P < .001), except for the ‘‘speech’’ score compared with the control

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EFFECTS OF SUBMUCOSAL DEXAMETHASONE AFTER MANDIBULAR FRACTURE SURGERY

group. The difference was also significant for the total duration of effect on the quality of life among the groups, except for the ‘‘appearance’’ score. Thus, patient-reported outcomes scales using questionnaires would have been a valuable tool to assess our patients’ perspectives rather than the grading scale of mild, moderate, and severe. This could be regarded as a limitation of our study. We encountered fever and infection as postoperative complications. Two patients from the steroid group developed an infection, with pus discharge from the surgical site during the follow-up period. The infections were treated with oral prophylaxis and oral antibiotics. Similarly, 4 patients in the steroid group and 2 in the control group developed postoperative fever during their hospital stay that was managed with antipyretics. The reasons for the postoperative infection after mandibular fracture could have been poor oral hygiene, a poor condition of the teeth in the fracture line, unsatisfactory patient compliance,35 fracture severity, aging, substance abuse, pre-existing systemic diseases,12 and so forth. The adverse effects associated with corticosteroid use include Cushing syndrome, hypothalamic-pituitaryadrenal suppression, posterior subcapsular cataracts, glaucoma, hypertension, myopathy, osteoporosis, alterations in mood or personality, psychosis, thin fragile skin, and impaired wound healing.36 Systemic or topical corticosteroids are absolutely contraindicated for patients with active, healed, or incompletely healed tuberculosis, ocular herpes simplex, primary glaucoma, or acute psychosis.22 Short-term use has not been associated with the known systemic side-effects of steroids such as poor wound healing, infection, or adrenal suppression.30,31 Exogenous corticosteroid use has been reported to have a negative feedback effect on the hypothalamus-pituitary-adrenal axis, resulting in suppression of the normal endogenous secretion of cortisol. The suppression reaches its maximum on the third day and will have normalized by the seventh day, which seems to be of little or no significance in the postoperative period. Problems only occur when this temporary suppression develops into a chronic state of adrenal suppression,29,37 which is less likely with a single dose of submucosal dexamethasone. In a study by Thoren et al,35 even a total perioperative dose equivalent to 30 mg dexamethasone used in association with repair of facial fractures did not significantly predispose the patients to a disturbance in surgical wound healing. To benefit from the effects of steroids, patients with mandibular fractures will probably require a higher steroid dose, because ORIF is far more extensive and time consuming than third molar extraction. Considering the studies35,38 with the safe use of higher doses of steroids, additional studies should be performed after controlling for other variables, such as oral hygiene, to determine the effective and safe dose. A reduction in

swelling around the wound should enhance the local circulation, which might paradoxically improve wound healing.39 The risk of systemic toxicity will also be reduced with submucosal administration. In conclusion, from the findings of the present study, it can be concluded that the submucosal administration of dexamethasone is a straightforward, relatively safe, effective, and inexpensive method, immediately after ORIF for mandibular fractures, effective in reducing postoperative pain and edema and trismus to a certain extent, with minimum adverse effects. Because our results seem promising, additional studies with a larger sample size are needed to definitely comment on the dose and efficacy of submucosal dexamethasone after ORIF for mandibular fractures.

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