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Not Yet Recruiting NCT07856875

Platelet-Rich Fibrin for Preventing Osteoradionecrosis After Dental Extractions

Conditions: Osteoradionecrosis of the Jaw

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 112
Sponsor: University of Manitoba

Location: Arthur J.E. Child Comprehensive Cancer Centre Dental Clinic Calgary Alberta

Summary

The goal of this clinical trial is to learn whether platelet-rich fibrin (PRF) can help prevent osteoradionecrosis (ORN) after dental extractions in adults who previously received radiation therapy to the head and neck. ORN is a condition in which jawbone damaged by radiation does not heal properly and may become exposed. The main question this study aims to answer is: Does placing PRF into dental extraction sites lower the chance of developing ORN within 6 months after extraction? PRF is made from a small sample of a participant's own blood. The blood is processed in a centrifuge to form PRF, which can then be placed into the tooth extraction site. Researchers will compare participants who receive PRF in addition to standard extraction care with participants who receive standard extraction care alone. Participants will: Have one or more teeth removed from an area of the jaw that previously received radiation therapy. Be randomly assigned to receive either PRF plus standard care or standard care alone. Return for follow-up visits at approximately 2 weeks, 6 weeks, 3 months, and 6 months after extraction. Have their healing, pain, any potential postoperative complications, and development of ORN assessed during follow-up.

Eligibility Criteria

Inclusion Criteria: Age 18 years or older. History of head and neck cancer treated with radiation therapy. Requires at least one dental extraction within an area of the jaw that was previously treated with radiation. Willing and able to attend all study follow-up visits. No minimum or maximum time since completion of radiation therapy is required. Exclusion Criteria: Abscess or draining sinus tract associated with a planned study extraction site. Blood disorder affecting platelet production or function, such as thrombocytopenia, hemophilia, von Willebrand disease, or a qualitative platelet disorder. Current immunosuppressive therapy, including calcineurin inhibitors, antimetabolites, biologic therapy, or active cytotoxic chemotherapy. Current tobacco use in any form, including nicotine vaping, within the previous 30 days. Known recurrence of head and neck cancer. Previous re-irradiation or re-irradiation currently planned. Chronic systemic corticosteroid use equivalent to at least 5 mg of prednisone daily for at least 30 consecutive days within the previous 3 months. Current or previous bisphosphonate therapy by any route. Denosumab within the previous 12 months or use of another antiresorptive or antiangiogenic medication. Current pregnancy. Therapeutic low-molecular-weight heparin or unfractionated heparin that cannot be scheduled at trough level.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07856875). StuddyBuddy aggregates publicly available trial information.