Topical Oxygen Therapy for BRONJ

NCT07725107 | Active Not Recruiting DMC

• 1 other identifier: R.26.02.104
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

BRONJ; MRONJ; blue®m; Oxygen-based therapy; Osteonecrosis of the jaw; Wound healing; Oral mucosal healing; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Complete mucosal healing (bone coverage)

  Mucosal healing will be evaluated clinically by direct inspection of the surgical site.

  12 weeks post-intervention

Secondary Outcomes (3)

• Soft-Tissue Healing

  - One week after intervention - 2 weeks after intervention - 4 weeks after intervention - 12 weeks after intervention

• Postoperative pain

  - 1 week postoperatively - 4 weeks postoperatively

• Hard Tissue

  - Preoperatively - 12 weeks postoperative

Study Arms (2)

Study Group 1

EXPERIMENTAL

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 2

EXPERIMENTAL

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

Interventions

Topical Blue®m application PROCEDURE

Intraoperative application of Blue®m oral gel to the debrided surgical site before primary closure

Study Group 1

PRF membrane placement PROCEDURE

Intraoperative placement of an autologous PRF membrane over the debrided surgical site before flap closure.

Study Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Previous radiotherapy to head and neck
• Uncontrolled systemic disease (e.g., uncontrolled diabetes)
• Pregnancy or lactation
• Known allergy to Blue®m components
• Uncooperative patients.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: April 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)