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Active, Not Recruiting

NCT Number: NCT07725107

Topical Oxygen Therapy for BRONJ

A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ) Bisphosphonate-Associated Osteonecrosis of the Jaw Bone Diseases Jaw Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Oxygen Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Topical Administration Wound Healing

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Mansoura University

Al Mansurah, Egypt

About this study

Thirty-six BRONJ/MRONJ patients will be randomly allocated to receive either Blue®m oral gel or PRF membrane following surgical debridement, and healing outcomes will be evaluated clinically.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical Blue®m application

Procedure

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

PRF membrane placement

Procedure

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

Primary outcomes

  1. Complete mucosal healing (bone coverage)

    Time frame: 12 weeks post-intervention

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

Secondary outcomes

  1. Soft-Tissue Healing

    Time frame: - One week after intervention - 2 weeks after intervention - 4 weeks after intervention - 12 weeks after intervention

    Soft tissue healing will be assessed using the Landry Healing Index, measured on a 5-point scale.

  2. Postoperative pain

    Time frame: - 1 week postoperatively - 4 weeks postoperatively

    Pain assessment will be evaluated using the Numeric Rating Scale (NRS), measured on a 0-10 scale.

  3. Hard Tissue

    Time frame: - Preoperatively - 12 weeks postoperative

    Bone density will be measured using CBCT at buccal, palatal, and apical aspects at coronal, middle, and apical levels, and the average value will be recorded.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Efficacy of Topically Applied Oxygen-Based Therapy Versus Platelet-Rich Fibrin for Medication-Related Osteonecrosis of the Jaws: A Randomized Controlled Trial

Acronym: OXY-BRONJ Tria

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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