Google Maps

NCT07725107

Overview

NCT ID: NCT07725107
Lead Sponsor: Mansoura UniversityOTHER
Official Title: Efficacy of Topically Applied Oxygen-Based Therapy Versus Platelet-Rich Fibrin for Medication-Related Osteonecrosis of the Jaws: A Randomized Controlled Trial
Brief Summary: A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients.
Conditions: Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)
Oxygen
Topical Administration
Wound Healing
Interventions

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Apr 1, 2026Actual
Primary Completion Date: Aug 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patient Age: ≥18 years.

Patients diagnosed with BRONJ/MRONJ Stage 1-3 (AAOMS criteria).(25)

History of antiresorptive or antiangiogenic drug use.

Patients willing to participate in the study's follow-up intervals and to provide informed consent.

Exclusion Criteria:

Previous radiotherapy to head and neck

Uncontrolled systemic disease (e.g., uncontrolled diabetes)

Pregnancy or lactation

Known allergy to Blue®m components

Uncooperative patients.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 36Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Faculty of Dentistry Mansoura University

Similar Studies

Participant Group/Arms

Study Group 1Experimental

18 patients diagnosed with BRONJ/MRONJ topical Blue®m oral gel were applied intraoperatively to the debrided bone surface and adjacent soft tissues before primary closure.

Procedure: Topical Blue®m application

Study Group 2Experimental

18 patients diagnosed with BRONJ/MRONJ autologous PRF membrane was prepared intraoperatively and placed over the debrided bone surface prior to flap closure.

Procedure: PRF membrane placement