Topical Oxygen Therapy for BRONJ

N/AActive Not RecruitingNCT07725107

Mansoura University36 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)Oxygen Topical Administration Wound Healing

Interventions

Topical Blue®m applicationPROCEDURE

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

PRF membrane placementPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

Complete mucosal healing (bone coverage)

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

Time frame: 12 weeks post-intervention

Secondary Outcomes

Soft-Tissue Healing

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

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

Postoperative pain

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

Time frame: - 1 week postoperatively - 4 weeks postoperatively

Hard Tissue

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.

Time frame: - Preoperatively - 12 weeks postoperative

Data from ClinicalTrials.gov

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