Root Coverage Performance of Restorative Materials in Class V Cavities
Clinical Evaluation of the Root Coverage Performance of Different Restorative Materials in Class V Cavities in Patients With Gingival Recession
연구 개요
상태
상세 설명
Gingival recession associated with non-carious cervical lesions (NCCLs) is a common clinical condition that may result in dentin hypersensitivity, root caries, and esthetic concerns. When root coverage surgery is indicated, the presence or absence of a cervical restoration and the type of restorative material may influence soft tissue healing and the stability of the surgical outcome. However, evidence regarding the optimal restorative approach before periodontal plastic surgery remains limited.
This prospective randomized controlled clinical trial will compare the clinical performance of different restorative approaches in Class V cervical lesions undergoing root coverage surgery with a subepithelial connective tissue graft. Eligible patients presenting with Cairo RT1 (Miller Class I-II equivalent) gingival recession and Class V cervical defects will be allocated to one of the study groups according to the study protocol. The interventions include restoration with glass ionomer cement, resin composite or no restoration when appropriate.
All participants will receive standardized periodontal treatment before surgery, followed by root coverage surgery using a subepithelial connective tissue graft. Clinical examinations will be performed at baseline and during follow-up to evaluate treatment outcomes.
The primary outcome is the percentage of root coverage achieved after surgery. Secondary outcomes include changes in gingival recession depth, clinical attachment level, keratinized tissue width, probing depth, dentin hypersensitivity, esthetic outcomes, and the clinical stability of the treated sites. The findings will help determine whether the restorative material placed in Class V cervical lesions influences the success of periodontal root coverage procedures.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Zeliha B ÇAKIR ERDİL, DDS
- 전화번호: +905059444038
- 이메일: bskcakirr@gmail.com
연구 연락처 백업
- 이름: Metin Çalışır, Prof.DR
- 이메일: metincalisir@adiyaman.edu.tr
연구 장소
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Merkez
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Adıyaman, Merkez, 터키 (Türkiye), 02030
- 모병
- Faculty of Dentistry, Adıyaman University
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연락하다:
- Zeliha B ÇAKIR ERDİL
- 전화번호: 05059444038
- 이메일: bskcakirr@gmail.com
-
부수사관:
- Zeliha Başak ÇAKIR ERDİL, DDS
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수석 연구원:
- METİN ÇALIŞIR, Prof.Dr.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Adults aged 18 years or older. Patients presenting with Cairo RT1 (Miller Class I or II equivalent) gingival recession defects requiring root coverage surgery.
Presence of a non-carious cervical lesion (NCCL), an existing cervical restoration, or a cervical defect requiring restoration.
Cervical lesion depth of ≤1.5 mm. Patients who have completed initial periodontal therapy before enrollment. Good oral hygiene (Plaque Index ≤20% or as determined by the investigator). Indication for root coverage surgery with a subepithelial connective tissue graft.
Teeth suitable for restoration with glass ionomer cement, resin composite, or flowable resin composite, or requiring no restoration according to the study protocol.
Ability and willingness to provide written informed consent and comply with study visits.
Exclusion Criteria:
- Age younger than 18 years. Pregnancy or breastfeeding. Poor oral hygiene. Uncontrolled systemic disease or any medical condition contraindicating periodontal surgery.
Bleeding disorders or current anticoagulation that contraindicates connective tissue graft harvesting.
Known allergy or hypersensitivity to resin composite, flowable resin composite, glass ionomer cement, or any study materials.
Patients who have not completed initial periodontal therapy. Cervical lesions deeper than 1.5 mm. Conditions that, in the investigator's opinion, could interfere with wound healing, periodontal surgery, or study outcomes.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: No Restoration Control Grou
Participants will be randomly assigned to one of three parallel groups: no restoration control, glass ionomer cement restoration, or resin composite restoration before root coverage surgery.
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No restorative material will be placed in the Class V cervical lesion before root coverage surgery.
Participants will undergo root coverage surgery using a coronally advanced flap with a subepithelial connective tissue graft according to the study protocol.
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실험적: Glass Ionomer Cement Group
Participants will receive restoration of the Class V cervical lesion with glass ionomer cement before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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실험적: Resin Composite Group
Participants will receive restoration of the Class V cervical lesion with resin composite before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Root Coverage
기간: Baseline to 6 months after surgery
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The percentage of root coverage will be evaluated after root coverage surgery in Class V cervical lesions treated with different restorative approaches, including glass ionomer, resin composite, flowable composite, or no restoration.
The outcome will assess which material or approach provides greater soft tissue coverage over the cervical/root surface.
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Baseline to 6 months after surgery
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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
키워드
기타 연구 ID 번호
- HRU-25.18.53
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
No Restoration Control Group에 대한 임상 시험
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Raphael Mendes Ritti Dias모병
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Queen Mary University of LondonUniversity of Belgrade아직 모집하지 않음
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Stanford UniversityLondon School of Hygiene and Tropical Medicine; National Institutes of Health (NIH); Catholic...아직 모집하지 않음시뮬레이션 교육 | 심한 폐렴 | 심각한 영양실조 | 심한 말라리아 | 신생아 소생술 | 심한 탈수 | 현직 교육 | 컴퓨터 보조 수업탄자니아