Autologous Platelet Concentrates on the Healing of Extraction Sockets (NCT07673848) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Autologous Platelet Concentrates on the Healing of Extraction Sockets
44 participantsStarted 2026-06-01
Plain-language 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. 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.
Who can participate
Age range
25 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)