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

NCT03269214 | Completed DMC

• 1 other identifier: 1396D22
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteonecrosis Due to Drugs, Jaw

Keywords

osteonecrosis; mandible

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Infection

  One month after treatment

• Infection

  Six months after treatment

• Infection

  12 months after treatment

Study Arms (2)

control group

NO INTERVENTION

Patients underwent debridement of necrotic bone and the involved area closed primary

treatment group

EXPERIMENTAL

Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.

Drug: Topical Phenytoin 5%

Interventions

Topical Phenytoin 5% DRUG

Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Related Publications (1)

• 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.

  PMID: 35866376 DERIVED

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither patients nor investigators were unaware about treatment and control groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of oral and maxillofacial surgery

Model Details: 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

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: August 31, 2017
• Study Start: September 1, 2012
• Primary Completion: October 31, 2016
• Study Completion: March 30, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share