Medication-related Osteonecrosis of the Jaw
Conditions
Brief 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.
Interventions
PROCEDUREApplication of A-PRF into extraction socket
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.
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proteomic biomarker expression changes in wound exudate (NSAF-based analysis) | 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. |
Outcome results
None listed