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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteonecrosis Due to Drugs, Jaw
• Intervention / Treatment: Drug: Topical Phenytoin 5%

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Collaborators: Shahid Beheshti University of Medical Sciences

Publications and helpful links

General Publications

• Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: August 27, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: osteonecrosis; mandible
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Phenytoin
• Other Study ID Numbers: 1396D22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We realize final results without any information about individuals who attended in this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No