Autologous Platelet Concentrates on the Healing of Extraction Sockets

Queen Mary University of London

Status

Begins enrollment in 1 month

Conditions

Medication-related Osteonecrosis of the Jaw

Treatments

Procedure: Application of A-PRF into extraction socket

Study type

Interventional

Funder types

Other

Identifiers

NCT07673848

IRAS: 368825

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)