The Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability
A Comparative Evaluation of the Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability : A Randomized Controlled Clinical Trial
The Primary Objectives of the present study are :
- To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood mesenchymal stem cells (PBMSCs) on implant stability.
- To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on implant stability.
調査の概要
詳細な説明
The addition of molecules or growth factors to the implant surface is an approach to enhance bone to implant contact (BIC).1 Platelet rich fibrin matrix (PRFM) is an autologous concentrated platelet-rich thrombin free fibrin matrix, prepared by two step centrifugation of blood. Platelets isolated, remain intact and retain their growth factor compliment. This allows a more effective, sustained release of growth factors to the wound site following PRFM application.2 During the second spin, a cross-linking of fibrin takes place, resulting in the formation of a dense fibrin matrix, within which a concentration of viable platelets can be found. Having an organized fibrin matrix at the start of healing accelerates the speed of vascular ingress into the wound compared to non-accelerated healing, which requires a longer time for fibrin formation and the development of vascularity. The earlier the vascularity is established, faster is the migration of the bone-forming cells at the wound site and initiation of bone formation. Therapeutic applications of platelet-rich products have led to improved bone regeneration and faster titanium implant osseointegration, which improve the stability and maintenance of dental implants by increasing BIC.1 Mesenchymal stem cells (MSCs) is a multipotent stromal cell with prominent regenerative functions. MSCs were first identified and isolated from bone marrow and then found in various tissues including umbilical cord, adipose tissue and peripheral blood. Among these sources peripheral blood MSCs draw increasing attention as they share similar biological characteristics with MSCs derived from bone marrow or adipose tissue. Bone marrow derived mesenchymal stem cells(BMMSCs) are multipotent cells capable of differentiating into osteoblasts, chondrocytes, adipocytes , fibroblasts, tenocytes, and myoblasts , which are considered as a cell source for various tissue repair and regenerating bone defects.3 The requirements of aspiration of bone marrow from the patient will cause pain and morbidity of the donor sites. It will be very convenient if peripheral blood mesenchymal stem cells (PBMSCs) could be harvested and expanded to enough numbers, with their osteogenic capacity maintained in a clinical permitted period.
The literature search does not show any human clinical trial conducted till date to assess the regenerative potential of this new modality i.e. PRFM and peripheral blood mesenchymal stem cells. This study therefore aims at the evaluation of PRFM and PBMSCs as regenerative materials for implant stability.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Karnataka
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Bengaluru、Karnataka、インド、560022
- 募集
- Kle Society'S Institute of Dental Sciences
-
コンタクト:
- laveena singhal, mds
- 電話番号:9900330579
- メール:laveenasinghal13@gmail.com
-
-
参加基準
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:
- Patient with age group between 25-50 years
- Radiographic imaging(IOPA/OPG/CBCT/RVG) of the area of interest showing sufficient residual bone volume to receive two or more adjacent implants of ≥ 3.5 mm in diameter and 11.0 mm in length
- Extraction at least 6 months prior to the study.
Exclusion Criteria:
- Para-functional habits
- Smoking more than 10 cigarettes per day
- Excessive consumption of alcohol
- Patient's with systemic diseases contraindicated for surgery
- Localized radiotherapy, Antitumor chemotherapy of the oral cavity
- Liver, blood, and/or kidney diseases
- Immunosuppression
- Current corticosteroid or bisphosphonate use;
- Pregnancy
- Mucocutaneous diseases involving the oral cavity and
- Poor oral hygiene.
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: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 |
|---|---|
|
アクティブコンパレータ:Dental Implant with PRFM
Intervention in the form of Dental Implants placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix a biological material procured from patient's peripheral blood
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placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM
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実験的:Dental Implant with PRFM and PBMSCs
Intervention in the form of Dental Implant placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix and peripheral blood mesenchymal stem cells which are the biological materials procured from patient's peripheral blood
|
placement of a minimum of two adjacent dental implants being randomly assigned into (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.
|
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 |
|---|---|---|
|
Insertion torque values at the time of placement of dental implant
時間枠:on the implant placement day
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insertion torque values will be recorded during the day of placement of implants.
|
on the implant placement day
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Implant stability quotient (ISQ) using Resonance frequency analysis (RFA).
時間枠:3 months
|
Implant stability quotient (ISQ) using Resonance frequency analysis (RFA) with the help of Osstell device at 1 week, 1 month and 3 months post operatively
|
3 months
|
協力者と研究者
捜査官
- 主任研究者:Sudhir R Patil, MDS、Kle Society'S Institute of Dental Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
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
- KLESInstitute
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?
IPD プランの説明
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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