Platelet-Rich Fibrin for Preventing Osteoradionecrosis After Dental Extractions
Multicentre Randomized Controlled Trial Evaluating Platelet-Rich Fibrin (PRF) for the Prevention of Osteoradionecrosis in Patients Requiring Dental Extractions After Radiation Therapy
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a multicentre, randomized controlled trial evaluating platelet-rich fibrin (PRF) for the prevention of osteoradionecrosis (ORN) following dental extraction in adults who have previously received radiation therapy involving the jaws.
Eligible participants requiring extraction of one or more teeth within a previously irradiated field will be randomized in a 1:1 ratio to receive either PRF plus standard extraction care or standard extraction care alone.
For participants allocated to the intervention group, autologous PRF will be prepared chairside from venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. The PRF will not be stored or transported.
The study will evaluate whether adjunctive PRF reduces the occurrence of ORN following dental extraction and will also evaluate clinical soft-tissue healing, radiographic bone healing, postoperative pain, analgesic use, postoperative complications, and adverse events.
The study will be conducted at participating centres in Winnipeg, Manitoba, and Calgary, Alberta, Canada.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Julia M Burgess, DMD (current OMFS Resident)
- 電話番号：6042206648
- メール：burges16@myumanitoba.ca
研究連絡先のバックアップ
- 名前：Reda Elgazzar, Oral and Maxillofacial Surgeon
- 電話番号：2047893634
- メール：Reda.Elgazzar@umanitoba.ca
研究場所
-
-
Alberta
-
Calgary、Alberta、カナダ、T2N 5G2
- Arthur J.E. Child Comprehensive Cancer Centre Dental Clinic
-
コンタクト：
- Dr. Edmund Chan, DMD
- 電話番号：587-231-5676
- メール：edmund.chan@albertahealthservices.ca
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コンタクト：
- Julia Burgess, DMD (Current OMFS Resident)
- メール：burges16@myumanitoba.ca
-
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British Columbia
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Vancouver、British Columbia、カナダ、V6T 1X4
- Health Sciences Centre Oral Surgery Clinic
-
コンタクト：
- Julia Burgess, DMD (Current OMFS Resident)
- 電話番号：204-787-3645
- メール：burges16@myumanitoba.ca
-
コンタクト：
- Reda Elgazzar, Oral and Maxillofacial Surgeon
- 電話番号：+12047893634
- メール：Reda.Elgazzar@umanitoba.ca
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Platelet-Rich Fibrin (PRF) + Standard Care
Participants randomized to this arm will undergo dental extraction with standard extraction care and adjunctive placement of autologous platelet-rich fibrin (PRF) into the extraction socket(s). PRF will be prepared chairside from the participant's venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. |
Autologous platelet-rich fibrin (PRF) will be prepared chairside from venous blood collected from the participant. Blood will be processed using horizontal centrifugation to produce PRF. The prepared PRF will be placed into the eligible dental extraction socket(s) during the same procedure. PRF will not be stored or transported. Participants will undergo extraction of one or more eligible teeth within a previously irradiated area of the jaw using standard dental extraction care. No platelet-rich fibrin (PRF) will be placed in the extraction socket(s) as part of this intervention. |
|
アクティブコンパレータ：Standard Care Alone
Participants randomized to this arm will undergo dental extraction with standard extraction care without placement of platelet-rich fibrin (PRF) into the extraction socket(s). |
Participants will undergo extraction of one or more eligible teeth within a previously irradiated area of the jaw using standard dental extraction care. No platelet-rich fibrin (PRF) will be placed in the extraction socket(s) as part of this intervention. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Osteoradionecrosis Within 6 Months
時間枠：From dental extraction through 6 months after extraction
|
Osteoradionecrosis (ORN) will be assessed at the participant level using the ClinRad definition adopted by the ISOO-MASCC-ASCO guideline. ORN is defined as a radiographic lytic or mixed sclerotic lesion of bone, visibly exposed bone, and/or bone probeable through a periodontal pocket or fistula within an anatomical site previously exposed to therapeutic head and neck radiation. A participant will meet the primary endpoint if at least one study extraction socket meets the definition at any scheduled or unscheduled visit through 6 months. |
From dental extraction through 6 months after extraction
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete Mucosal Closure of the Extraction Site
時間枠：2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
Complete mucosal closure will be assessed clinically at each study extraction socket and recorded as a binary outcome (yes/no). Complete mucosal closure is defined as intact epithelium across the entire socket orifice, with no dehiscence and no exposed bone. Socket-level outcomes will account for clustering of multiple extraction sockets within individual participants. |
2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
|
Radiographic Bone Healing at the Extraction Site
時間枠：Baseline to 6 months after dental extraction
|
Radiographic bone healing at each study extraction site will be assessed by qualitative comparison of the 6-month cone-beam computed tomography (CBCT) scan with the pre-extraction baseline CBCT. Assessment will include the presence, absence, and extent of lytic or mixed sclerotic changes and cortical continuity at the socket crest. |
Baseline to 6 months after dental extraction
|
|
Postoperative Pain Intensity
時間枠：2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
Pain intensity at each study extraction socket will be assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will rate pain at each extraction site over the preceding 24 hours. Higher scores indicate greater pain intensity. |
2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Julia M Burgess, DMD (current OMFS Resident)、University of Manitoba
- スタディディレクター：Reda Elgazzar, Oral and Maxillofacial Surgeon、University of Manitoba
- スタディディレクター：Edmund Chan, DMD、University of Calgary
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- PRF-ORN-RCT-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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