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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 31, 2016

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.

Interventions

  • Drug: Topical Phenytoin 5%
    • Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Infection
    • Time Frame: One month after treatment
    • Any sign of pus or fistula tract in treatment area
  • Infection
    • Time Frame: Six months after treatment
    • Any sign of pus or fistula tract in treatment area
  • Infection
    • Time Frame: 12 months after treatment
    • Any sign of pus or fistula tract in treatment area

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shiraz University of Medical Sciences
  • Collaborator
    • Shahid Beheshti University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Reza Tabrizi, associate professor of oral and maxillofacial surgery – Shiraz University of Medical Sciences

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