Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible

Study Overview
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Brief Summary
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Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated in two groups randomly : In group1, 10 patients underwent debridement and primary closer of the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.

Detailed Description
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All patients undergo surgical necrotic bone debridement in combination with antibiotic therapy (clindamycin 300 mg q8h) for 4 weeks . Patients who had BRON of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline. Patients were evaluated after 1(time1) ,6(time2) and 12(time 3) months. The size of bone lesion was measured by using come beam computer tomography (CBCT). Wound dehiscence (Stage 0 :No dehiscence ,Stage 1: less than 10 mm dehiscence,stage 2 : more than 10 mm dehiscence) Infection: Pus, sinus tract (Yes/NO) Pain according to visual analog scale (VAS) 0-10.In the third follow up time ( 12 months) ,the number of patients who were a time span of 3 months without clinical symptoms were documented in each group.

Official Title
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Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study

Conditions
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Osteonecrosis Due to Drugs, Jaw

Intervention / Treatment
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* Drug: Topical Phenytoin 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria of bisphosphonate-related Osteonecrosis in stage II need debridement and surgical intervention Exclusion Criteria: Malignancy in the area History of chemotherapy , diabetic mellitus HIV odontogenic infection or undergo dialysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who had bisphosphonate-related osteonecrosis of the jaw of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Patients underwent debridement of necrotic bone and the involved area closed primary | |
| Experimental: treatment group<br>Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure. | Drug: Topical Phenytoin 5%<br>* Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue healing | Appropriate soft tissue healing was defined when no dehiscence occurred | After one month | 
| Soft tissue healing | Appropriate soft tissue healing was defined when no dehiscence occurred | Six months after treatment | 
| Soft tissue healing | Appropriate soft tissue healing was defined when no dehiscence occurred | 12 months after treatment | 
| Pain | Based on visual analogue scale 0-10 | one month after treatment | 
| Pain | Based on visual analogue scale 0-10 | Six months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Any sign of pus or fistula tract in treatment area | One month after treatment | 
| Infection | Any sign of pus or fistula tract in treatment area | Six months after treatment | 
| Infection | Any sign of pus or fistula tract in treatment area | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mandible, osteonecrosis