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

Osteonecrosis Due to Drugs, Jaw Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis Due to Drugs, Jaw

• NCT number: NCT03269214
• Study type: Interventional
• Source: Shiraz University of Medical Sciences
• Status: Completed
• Phase: N/A
• Start date: September 1, 2012
• Completion date: March 30, 2017