Medication-related Osteonecrosis of the JawNCT07673848
Autologous Platelet Concentrates on the Healing of Extraction Sockets
A study testing Application of A-PRF into extraction socket in people with Medication-related Osteonecrosis of the Jaw, run by Queen Mary University of London.
Trial summary
This study will evaluate the effect of A-PRF, a second-generation APC, on early wound healing in high-risk MRONJ patients following dental extractions, utilising advanced non-invasive methods to assess and associate molecular and blood flow changes during early healing. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Medication-related Osteonecrosis of the Jaw
- What is being tested?
- Application of A-PRF into extraction socket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2029
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligibility criteria
All of the following criteria must be fulfilled for inclusion:
- Patient must be willing to read and sign a copy of the Informed Consent Form
- Males and females ≥ 25 years old;
- Patients who are currently or previously treated with antiresorptive therapy alone or in combination with immune modulators or antiangiogenic medications for the management of cancer;
- Patients who are treated with antiresorptive therapy, bisphosphonates, for osteoporosis for more than 5 years;
- Patients who have been treated with antiresorptive therapy, bisphosphonates, for osteoporosis for less than 5 years and being concurrently treated with a systemic glucocorticoid;
- Patients who are treated with denosumab in the last nine months and being concurrently treated with a systemic glucocorticoid;
- Patients who are on the high-risk category to develop MRONJ based on the SDCEP guidance;
- Patients who require dental extractions (one per quadrant per patient) of premolar or molar teeth which are irrational to treat for any reason;
- Patients with a history of MRONJ.
The following patients will be excluded:
- Patients with MRONJ at the area of extraction;
- Patients with history of radiotherapy in the area of treatment;
- Patients with metastatic bone disease in the area of treatment;
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;
- Dental extractions in people who are systemically unwell and who require hospital admission;
- Patients with poor glycaemic control (uncontrolled diabetes);
- Current smokers or smokers who have quit less than 10 years ago (including e-cigarettes)
About this study
Official title: The Role of Autogenous Platelet Concentrates (APCs) in Post-extraction Early Wound Healing of High-risk Medication Related Osteonecrosis of the Jaw (MRONJ) Patients.
This study will evaluate the effect of A-PRF, a second-generation APC, on early wound healing in high-risk MRONJ patients following dental extractions, utilising advanced non-invasive methods to assess and associate molecular and blood flow changes during early healing. The early healing events of the post-extraction socket will also be characterised in terms of volumetric changes in relation to intra-oral thermographic changes, blood flow changes, in tandem with clinical measures of soft tissue healing and post-operative pain assessment. The early healing events will be analysed up to 15 days, and the final recall will be 180 days after extraction.
- Being tested
- Application of A-PRF into extraction socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of A-PRF into extraction socketProcedure or surgery
For patients in the A-PRF group, venepuncture will be performed with a tourniquet, a butterfly needle (such as a 21-gauge Vacutainer Safety-Lok), and A-PRF blood bottles. Two 10 mL vials of blood will be obtained. The vials will be centrifuged at 1300 rpm using the Choukroun Duo Quattro PRF Centrifuge for 14 min. For patients on anticoagulant medication, the vials will undergo further centrifugation for 2 minutes.
The A-PRF clots are then removed from the tube and separated from the red blood cells and platelet-poor plasma. They are then placed in an expression kit for 10 min (which will be monitored using a timer) to drain and compress.
Once the membranes have been compressed for at least 10 minutes, they will be placed in the extraction socket and secured with 4-0 PTFE sutures.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MRONJ | Experimental | A-PRF extraction sockets Receives: Procedure: Application of A-PRF into extraction socket |
| Control | No intervention | Unassisted extraction sockets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)
Wound exudate from the three groups will be analysed to assess for changes in protein expression and signalling pathways during early wound healing. A small sterile medical grade PVA sponge will be used to collect the wound exudate from the extraction socket (such as NETCELL® PVA Microspheres, Network Medical Products Ltd, North Yorkshire, UK).
Analytes involved in the healing process such as angiogenesis, wound healing, inflammation, bone remodelling, and formation will be selected based on the pathways identified in the genomic and proteomic work and literature search performed by our group. Multiplex (Luminex, R\&D systems, Minneapolis, MN, USA) immunoassays will be designed specifically for quantitative analyses in the wound exudate of the socket. The molecular (proteomic) changes of wound exudate of the dental extraction socket will be assessed at 1, 3, 7, 15 days after extraction based on the Normalised Spectral Abundance Factor (NSAF) proteomic analysis.
Measured: At 1, 3, 7 and 15 days post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-related Osteonecrosis of the JawStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Experimental intervention - A-PRF preparation Venipuncture and collection of blood in 10 ml tubes (2 tubes) Centrifugation (BTI SYSTEM IV® Model Centrifuge) at 1300 rpm with centrifuge machine for 14 min PRF clots are removed from the tube and separated from red blood cells and platelet-poor plasma. They are then placed in an expression kit for 10 min to drain and compress.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673848
- Sponsor's protocol ID
- IRAS: 368825
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Autogenous Platelet Concentrates (APCs) in Post-extraction Early Wound Healing of High-risk Medication Related Osteonecrosis of the Jaw (MRONJ) Patients.
- ClinicalTrials.gov ID
- NCT07673848
- Acronym / sponsor ID
- IRAS: 368825
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 29 Jun 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.
This study will evaluate the effect of A-PRF, a second-generation APC, on early wound healing in high-risk MRONJ patients following dental extractions, utilising advanced non-invasive methods to assess and associate molecular and blood flow changes during early healing. The early healing events of the post-extraction socket will also be characterised in terms of volumetric changes in relation to intra-oral thermographic changes, blood flow changes, in tandem with clinical measures of soft tissue healing and post-operative pain assessment. The early healing events will be analysed up to 15 days, and the final recall will be 180 days after extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental intervention - A-PRF preparation Venipuncture and collection of blood in 10 ml tubes (2 tubes) Centrifugation (BTI SYSTEM IV® Model Centrifuge) at 1300 rpm with centrifuge machine for 14 min PRF clots are removed from the tube and separated from red blood cells and platelet-poor plasma. They are then placed in an expression kit for 10 min to drain and compress.
| Arm | Type | Receives |
|---|---|---|
| Patients with MRONJ | Experimental | Procedure: Application of A-PRF into extraction socketA-PRF extraction sockets |
| Control | No intervention | –Unassisted extraction sockets |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Application of A-PRF into extraction socketFor patients in the A-PRF group, venepuncture will be performed with a tourniquet, a butterfly needle (such as a 21-gauge Vacutainer Safety-Lok), and A-PRF blood bottles. Two 10 mL vials of blood will be obtained. The vials will be centrifuged at 1300 rpm using the Choukroun Duo Quattro PRF Centrifuge for 14 min. For patients on anticoagulant medication, the vials will undergo further centrifugation for 2 minutes. The A-PRF clots are then removed from the tube and separated from the red blood cells and platelet-poor plasma. They are then placed in an expression kit for 10 min (which will be monitored using a timer) to drain and compress. Once the membranes have been compressed for at least 10 minutes, they will be placed in the extraction socket and secured with 4-0 PTFE sutures. | Procedure or surgery | Patients with MRONJ |
Primary outcome
Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)
Time frame: At 1, 3, 7 and 15 days post-extraction
Wound exudate from the three groups will be analysed to assess for changes in protein expression and signalling pathways during early wound healing. A small sterile medical grade PVA sponge will be used to collect the wound exudate from the extraction socket (such as NETCELL® PVA Microspheres, Network Medical Products Ltd, North Yorkshire, UK). Analytes involved in the healing process such as angiogenesis, wound healing, inflammation, bone remodelling, and formation will be selected based on the pathways identified in the genomic and proteomic work and literature search performed by our group. Multiplex (Luminex, R\&D systems, Minneapolis, MN, USA) immunoassays will be designed specifically for quantitative analyses in the wound exudate of the socket. The molecular (proteomic) changes of wound exudate of the dental extraction socket will be assessed at 1, 3, 7, 15 days after extraction based on the Normalised Spectral Abundance Factor (NSAF) proteomic analysis.
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 1 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Application of A-PRF into extraction socket in people with Medication-related Osteonecrosis of the Jaw, run by Queen Mary University of London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Proteomic biomarker expression changes in wound exudate (NSAF-based analysis) (time frame: At 1, 3, 7 and 15 days post-extraction). 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 1 Sep 2026.