Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects
Injectable Platelet-Rich Fibrin (i-PRF) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
연구 개요
상태
상세 설명
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the periodontal supporting tissues, ultimately leading to tooth loss if left untreated.
Optimal periodontal regeneration within intrabony defects depends on the preservation of soft tissues and the maintenance of primary wound closure. Minimally invasive non-surgical periodontal therapy (MINST) has been introduced as a concept aiming to obtain extensive subgingival debridement with minimal tissue trauma.
Platelet-rich plasma (PRP) is an autologous blood product which is created through the centrifugation process of whole blood. It is defined as having a platelet concentration above that of normal physiological levels. The platelets present in PRP carry granules containing a significant number of active biomolecules.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Amir R Elngar, B.D.S
- 전화번호: 00201004634587
- 이메일: amirreda059@gmail.com
연구 장소
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Cairo, 이집트, 12511
- 모병
- October 6 University
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연락하다:
- Amir R Elngar, B.D.S
- 전화번호: 00201004634587
- 이메일: amirreda059@gmail.com
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부수사관:
- Reham L Aggour, MD
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부수사관:
- Amany A Alaraby, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients of both genders >18 years old, medically free of systemic diseases affecting periodontal regeneration.
- Diagnosis of 'periodontitis' stage III (grades B or C).
- Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.
- Presence of comparable bilateral two- or three-walled intrabony defects [probing pocket depth (PPD), > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph] not in a furcation-involved tooth.
Exclusion Criteria:
- Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
- Pregnant and lactating women
- Current use of any form of tobacco.
- Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
- Degree 2 or 3 mobility of the involved sites.6.
- Presence of periapical pathology, acute infection, or subgingival restoration which could interfere with clinical measurements.
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: Group 1 (control group)
Patients will receive minimally invasive non-Surgical technique (MINST) alone
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Patients will receive minimally invasive non-Surgical technique (MINST) alone
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실험적: Group 2 (Test group)
Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection
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Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Presence of comparable bilateral-walled intrabony defects
기간: 6 months postoperatively
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Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique. Presence of comparable bilateral-walled intrabony defects (PPD, > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth. |
6 months postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical attachment level
기간: 6 months postoperatively
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Clinical attachment level (CAL) will be measured in millimeters from the cemento-enamel junction (CEJ) to the base of the periodontal sulcus at 6 sites per tooth
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6 months postoperatively
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Interproximal probing depth
기간: 6 months postoperatively
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Probing depth (PD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth
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6 months postoperatively
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Gingival margin
기간: 6 months postoperatively
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Gingival margin will be measured from the cemento-enamel junction (CEJ).
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6 months postoperatively
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Bleeding on probing
기간: 6 months postoperatively
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Bleeding on Probing (BoP) will be measured using papillary bleeding index that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus
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6 months postoperatively
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Plaque index
기간: 6 months postoperatively
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Plaque index (PI) will be measured for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin
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6 months postoperatively
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공동 작업자 및 조사자
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
기타 연구 ID 번호
- 23110280p
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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