Treating Intrabony Defect With MINST VS MINST Extended PRF (MINST PRF)
Clinical Effectiveness of Minimally Invasive Non-surgical Technique With or Without Extended Platelets Rich Fibrin in Intrabony Defects: a Randomized Controlled Clinical Trial
This study evaluates a minimally invasive non-surgical technique (MINST) for treating periodontal intrabony defects, with or without the addition of Extended Platelet-Rich Fibrin (e-PRF). The goal is to determine which approach provides better bone regeneration and gum healing.
Study Procedures
Control Group:
Local anesthesia by infiltration at the treatment site
Instrumentation of the root surface up to the bottom of the periodontal pocket
Efforts are made to minimize trauma to soft tissues and interdental papilla using subpapillary access
Cleaning is performed using piezo-electric devices with delicate tips, avoiding aggressive root smoothing or gingival curettage
3-4× magnification loupes are used to improve precision
Intervention Group:
All the above procedures
Followed by injection of e-PRF, a preparation derived from the patient's own blood
Blood is collected in 4 mL tubes and centrifuged at 700 g for 8 minutes
The platelet-poor plasma is heated to create an albumin gel
The remaining buffy coat (rich in platelets and growth factors) is mixed with the cooled albumin gel to form Alb-PRF, which is applied to the defect
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Samuel Michael Mikhail, B.Sc.
- 전화번호: +201117776200
- 이메일: samuel.girgis@dentistry.cu.edu.eg
연구 장소
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Giza Governorate
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Giza, Giza Governorate, 이집트, 12613
- 모병
- Faculty of Dentistry, Cairo University
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연락하다:
- Samuel Mikhail, B.Sc.
- 전화번호: +201117776200
- 이메일: samuel.girgis@dentistry.cu.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Adults aged above 21 years. Clinical diagnosis of Stage III periodontitis. Presence of at least two isolated interproximal intrabony defects located in different quadrants.
Intrabony defect associated with a single-rooted tooth or mandibular molar without furcation involvement.
Probing depth (PD) ≥ 6 mm. Radiographic intrabony defect depth between 3 and 7 mm. Absence of periapical pathology at the study site. Absence of acute periodontal infection. Absence of subgingival restorations that could interfere with clinical measurements.
Absence of Grade II or Grade III tooth mobility. Ability and willingness to provide written informed consent.
Exclusion Criteria:
Pregnancy or lactation. Non-surgical periodontal therapy within the previous 6 months. Surgical periodontal therapy within the previous 12 months. History of radiotherapy to the head and neck region. Current smoking.
Eligibility note: Former smokers and never-smokers are eligible.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: MINST Alone
Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) alone. The procedure will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. No platelet-rich fibrin or other regenerative biomaterial will be applied. |
Modified minimally invasive non-surgical periodontal therapy performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes. The procedure aims to thoroughly debride the periodontal pocket while minimizing soft tissue trauma and preserving root cementum by avoiding intentional root surface smoothing and gingival curettage. |
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실험적: MINST + Extended Platelet-Rich Fibrin (e-PRF)
Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) followed by the application of autologous extended platelet-rich fibrin (e-PRF) into the intrabony periodontal defect. MINST will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. The e-PRF will be prepared from the participant's peripheral blood by combining heated albumin gel with liquid platelet-rich fibrin before placement into the defect. The protocol follows the procedures described in the study protocol |
Modified minimally invasive non-surgical periodontal therapy performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes. The procedure aims to thoroughly debride the periodontal pocket while minimizing soft tissue trauma and preserving root cementum by avoiding intentional root surface smoothing and gingival curettage. Autologous extended platelet-rich fibrin (e-PRF) prepared from the participant's peripheral blood. Whole blood is centrifuged to obtain liquid platelet-rich fibrin, while the platelet-poor plasma is heated to form denatured albumin gel. The cooled albumin gel is mixed with the liquid platelet-rich fibrin to produce e-PRF, which is applied into the periodontal intrabony defect immediately after completion of the MINST procedure |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Probing Depth (PD)
기간: Baseline and 6 months after treatment
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Change in periodontal probing depth (PD), measured in millimeters using a UNC-15 periodontal probe with a standardized probing force. Measurements are obtained using a patient-specific acrylic stent to ensure reproducibility. |
Baseline and 6 months after treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Attachment Level (CAL)
기간: Baseline, 3 months, and 6 months after treatment
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Baseline, 3 months, and 6 months after treatment
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Change in Gingival Recession (GR) measured using a UNC-15 periodontal probe
기간: Baseline, 3 months, and 6 months after treatment
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Baseline, 3 months, and 6 months after treatment
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Change in Radiographic Intrabony Defect Depth measured using standardized periapical radiographs and ImageJ software
기간: Baseline and 6 months after treatment
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Baseline and 6 months after treatment
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Patient Satisfaction (VAS)
기간: During the first postoperative week after treatment
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0 indicates no pain or discomfort and 10 indicates the worst imaginable pain or discomfort. |
During the first postoperative week after treatment
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20.
- Miron RJ, Pikos MA, Estrin NE, Kobayashi-Fujioka M, Espinoza AR, Basma H, Zhang Y. Extended platelet-rich fibrin. Periodontol 2000. 2024 Feb;94(1):114-130. doi: 10.1111/prd.12537. Epub 2023 Nov 20.
- Ribeiro FV, Mehta JJ, Monteiro MF, Moore J, Casati MZ, Nibali L. Minimal invasiveness in nonsurgical periodontal therapy. Periodontol 2000. 2023 Feb;91(1):7-19. doi: 10.1111/prd.12476. Epub 2023 Jan 20.
- Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.
- Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Ext-prf-defect
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, baseline clinical measurements, outcome measures, and follow-up data.
IPD 공유 기간
Start: 6 months after publication of the primary results End: 5 years after publication of the primary results
IPD 공유 액세스 기준
De-identified individual participant data, the study protocol, the statistical analysis plan, and the informed consent form will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the Principal Investigator. Access will be provided after review and approval of the proposal and execution of a data use agreement, with data shared in a secure electronic format.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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