Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)OXY-BRONJ TriaNCT07725107
Topical Oxygen Therapy for BRONJ
A study testing Topical Blue®m application and PRF membrane placement in people with Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ) and Oxygen, run by Mansoura University at 1 site in Egypt.
Trial summary
A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen, Topical Administration
- What is being tested?
- Topical Blue®m application and PRF membrane placement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Previous radiotherapy to head and neck
- Uncontrolled systemic disease (e.g., uncontrolled diabetes)
- Pregnancy or lactation
- Known allergy to Blue®m components
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topically Applied Oxygen-Based Therapy Versus Platelet-Rich Fibrin for Medication-Related Osteonecrosis of the Jaws: A Randomized Controlled Trial
A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients.
Read the detailed description
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.
- Conditions
- Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen, Topical Administration, Wound Healing
- Being tested
- Topical Blue®m application, PRF membrane placement
- Keywords
- BRONJ, MRONJ, blue®m, Oxygen-based therapy, Osteonecrosis of the jaw, Wound healing, Oral mucosal healing, Randomized clinical trial
- Medical subject headings
- Bisphosphonate-Associated Osteonecrosis of the Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Blue®m applicationProcedure or surgery
Intraoperative application of Blue®m oral gel to the debrided surgical site before primary closure
PRF membrane placementProcedure or surgery
Intraoperative placement of an autologous PRF membrane over the debrided surgical site before flap closure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: PRF membrane placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete mucosal healing (bone coverage)
Mucosal healing will be evaluated clinically by direct inspection of the surgical site.
Measured: 12 weeks post-intervention
Secondary outcomes (3)
Soft-Tissue Healing
Soft tissue healing will be assessed using the Landry Healing Index, measured on a 5-point scale.
Measured: - 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.
Measured: - 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.
Measured: - Preoperatively - 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Apr 2026
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725107
- Sponsor's protocol ID
- R.26.02.104
- Acronym
- OXY-BRONJ Tria
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topically Applied Oxygen-Based Therapy Versus Platelet-Rich Fibrin for Medication-Related Osteonecrosis of the Jaws: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07725107
- Acronym / sponsor ID
- OXY-BRONJ Tria / R.26.02.104
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized clinical trial comparing Blue®m oral gel and autologous PRF membrane as adjuncts to surgical debridement in BRONJ/MRONJ patients.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Procedure: Topical Blue®m application18 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. |
| Study Group 2 | Experimental | Procedure: PRF membrane placement18 patients diagnosed with BRONJ/MRONJ autologous PRF membrane was prepared intraoperatively and placed over the debrided bone surface prior to flap closure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Previous radiotherapy to head and neck
- Uncontrolled systemic disease (e.g., uncontrolled diabetes)
- Pregnancy or lactation
- Known allergy to Blue®m components
- Uncooperative patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Blue®m applicationIntraoperative application of Blue®m oral gel to the debrided surgical site before primary closure | Procedure or surgery | Study Group 1 |
| PRF membrane placementIntraoperative placement of an autologous PRF membrane over the debrided surgical site before flap closure. | Procedure or surgery | Study Group 2 |
Primary outcome
Complete mucosal healing (bone coverage)
Time frame: 12 weeks post-intervention
Mucosal healing will be evaluated clinically by direct inspection of the surgical site.
3 secondary outcomes
Soft-Tissue Healing
Time frame: - One week after intervention - 2 weeks after intervention - 4 weeks after intervention - 12 weeks after intervention
Postoperative pain
Time frame: - 1 week postoperatively - 4 weeks postoperatively
Hard Tissue
Time frame: - Preoperatively - 12 weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)
Active, not recruitingPhase 3
Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ)
Medication-related Osteonecrosis of the Jaw, Bisphosphonate-related Osteonecrosis of the Jaw
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Blue®m application and PRF membrane placement in people with Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ) and Oxygen, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete mucosal healing (bone coverage) (time frame: 12 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.