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

Not Applicable

Completed

• Conditions: Osteonecrosis Due to Drugs, Jaw
• Interventions: Drug: Topical Phenytoin 5%

• Registration Number: NCT03269214
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-09-01
• Primary Completion: 2016-10-31
• Study Completion: 2017-03-30
• Status Verified: 2017-08
• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Criteria of bisphosphonate-related Osteonecrosis in stage II
• need debridement and surgical intervention

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Exclusion Criteria

• Malignancy in the area
• History of chemotherapy ,
• diabetic mellitus
• HIV
• odontogenic infection or undergo dialysis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Topical Phenytoin 5%	Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.

Primary Outcome Measures

Name	Time	Method
Pain	Six months after treatment	Based on visual analogue scale 0-10
Soft tissue healing	12 months after treatment	Appropriate soft tissue healing was defined when no dehiscence occurred

Secondary Outcome Measures

Name	Time	Method
Infection	12 months after treatment	Any sign of pus or fistula tract in treatment area