Autologous Platelet Concentrates on the Healing of Extraction Sockets
The Role of Autogenous Platelet Concentrates (APCs) in Post-extraction Early Wound Healing of High-risk Medication Related Osteonecrosis of the Jaw (MRONJ) Patients.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
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
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)
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：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Patients with MRONJ
A-PRF extraction sockets
|
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. |
|
介入なし：Control
Unassisted extraction sockets
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)
時間枠：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. |
At 1, 3, 7 and 15 days post-extraction
|
協力者と研究者
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
その他の研究ID番号
- IRAS: 368825
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。