L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0
Role of Platelet-Rich Fibrin in the Prevention of Osteoradionecrosis and Medication-related Osteonecrosis of the Jaw Following Tooth Extractions: A Prospective, Triple-Blind, Randomised Feasibility Trial
Osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ) are debilitating complications following dental extractions in patients who have received head and neck radiotherapy or antiresorptive therapy. These conditions are associated with significant morbidity, including persistent pain, poor oral function, and reduced quality of life.
While preventive strategies remain limited, platelet-rich fibrin (L-PRF), an autologous fibrin matrix enriched with growth factors, has shown potential in promoting wound healing and modulating inflammation. This prospective, triple-blind, randomised pilot trial aims to evaluate the effectiveness of L-PRF in enhancing socket healing and reducing the incidence of ORN and MRONJ. Forty patients (20 post-radiotherapy, 20 on antiresorptive agents) undergoing non-surgical dental extractions will be randomised to receive either L-PRF or standard care. The primary outcome is mucosal healing at Day 10 post-extraction, assessed using the Landry wound healing index. Secondary outcomes include the incidence of ORN or MRONJ at extraction sites assessed at 9, 17, 25, and 52 weeks. This study aims to provide early evidence on the clinical utility of L-PRF in preventing osteonecrosis in high-risk patients.
調査の概要
状態
詳細な説明
Osteoradionecrosis (ORN) is a condition in which necrosis of the jawbone occurs in patients who have previously undergone radiotherapy for head and neck cancer. Medication-Related Osteonecrosis of the Jaw (MRONJ) occurs in patients receiving, or who have received, antiresorptive therapies such as bisphosphonates or denosumab. Both conditions share underlying mechanisms including impaired bone healing, chronic inflammation, and disrupted angiogenesis . Patients in either group face an increased risk of poor healing following tooth extraction, which can result in persistent pain, infection, and progressive jawbone necrosis. These complications profoundly impair patients' abilities to eat and speak, significantly reducing their quality of life.
ORN and MRONJ are extremely difficult to predict, prevent, and manage. Treatment typically requires removal of necrosed bone followed by complex reconstructive procedures that consume significant hospital resources, including materials, staff time, and prolonged hospital stays. Despite these interventions, patients often experience substantial reductions in quality of life. The economic burden on the NHS and responsible trusts is considerable, underscoring the urgent need for improved preventive approaches.
Leukocyte- and platelet- rich fibrin (L-PRF), an autologous leukocyte and platelet concentrate, has demonstrated promising results in promoting soft tissue and bone healing, owing to its angiogenic, anti-inflammatory, and regenerative properties . Its use in dental extractions could mitigate the risk of developing ORN or MRONJ in high-risk populations.
L-PRF is a second-generation platelet concentrate that releases growth factors such as PDGF, TGF-β, and VEGF over an extended period. In vitro studies show that its three-dimensional fibrin matrix continuously releases these factors and cytokines for up to 21 days, which helps regulate inflammation and promote angiogenesis, supporting tissue healing.
L-PRF, a second-generation platelet concentrate, has gained popularity in oral surgery and periodontal procedures (12) with evidence suggesting faster mucosal healing and reduced post-operative complications, because of a slower, continuous release of growth factors when compared to other concentrates in vitro. Furthermore, the leukocytes presented in L-PRF may synthesize several pro- and anti-inflammatory cytokines as well.
However, controlled data on its use specifically for ORN or MRONJ prevention is scarce. Small case series and observational studies suggest improved outcomes, but robust trial data is lacking.
Given the significant morbidity associated with ORN and MRONJ and the lack of proven preventive strategies, evaluating L-PRF in a clinical trial setting is justified. The intervention is autologous and low-risk. Potential benefits include enhanced mucosal healing and reduced incidence of osteonecrosis. Risks are minimal and largely relate to venepuncture or standard surgical procedures. The trial aims to determine feasibility, safety, and early efficacy signals to inform future large-scale trials.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Partha S Chakraborty
- 電話番号:+44 7867063718
- メール:Partha.Chakraborty@wales.nhs.uk
研究場所
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Swansea、イギリス、SA6 6NL
- Morriston Hospital
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コンタクト:
- Partha S Chakraborty
- 電話番号:+44 7867063718
- メール:Partha.Chakraborty@wales.nhs.uk
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主任研究者:
- Partha S Chakraborty
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
-General Inclusion Criteria (Applies to All Participants)
Age ≥18 years
Requiring extraction of one or more teeth with hopeless prognosis
Capacity to provide informed consent
Ability and willingness to attend all scheduled follow-up visits over 12 months
-Post-Radiotherapy Group - Specific Inclusion
Previous radiotherapy to the head and neck region
Documented radiation dose ≥50 Gy
Radiotherapy records (dose, field, date) must be available
-Antiresorptive Group - Specific Inclusion
Current or prior use of antiresorptive agents (e.g. bisphosphonates or denosumab)
Medication history must be available in medical records
Exclusion Criteria:
- General Exclusion Criteria (Applies to All Participants)
Inability to maintain adequate oral hygiene due to motor disability
Uncontrolled systemic illness (e.g. uncontrolled diabetes)
Use of anticoagulants, immunosuppressants, or medications known to impair healing
Requirement for surgical (complex) extractions
Enrolment in another clinical trial
Known allergy to anaesthetic agents, L-PRF components, or antibiotics used in perioperative protocol
Anticipated non-compliance with follow-up
-Post-Radiotherapy Group - Specific Exclusion
Previous or current antiresorptive therapy
History of re-irradiation or radiation dose <50 Gy
-Antiresorptive Group - Specific Exclusion
History of head and neck radiotherapy
Neoplastic involvement of the jaws
Active untreated oral infection or pathology at time of planned extraction
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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター:対照群
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No L-PRF will be placed in the post-extraction sockets
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実験的:L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF)
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L-PRF is made from the patient's own blood and contains natural healing cells and growth factors.
It is already used in other areas of dentistry to help wounds heal, but it is not yet clear whether it helps prevent jawbone necrosis in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications.
This study will help us understand whether using L-PRF during extractions makes healing faster and safer and can can prevent or reduce the chance of developing osteoradionecrosis or MRONJ in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications respectively.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.
時間枠:Day !0
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Day !0
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二次結果の測定
結果測定 |
時間枠 |
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Incidence of ORN and MRONJ at the extraction sites
時間枠:assessed at 9, 17, 25 weeks and 12 months post-extraction.
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assessed at 9, 17, 25 weeks and 12 months post-extraction.
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協力者と研究者
捜査官
- スタディチェア:Ketan R Shah, FRCS、Swansea Bay University Health Board
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SBU62
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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