- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07679152
Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals
Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals in Permanent Mature Vital Teeth
Statement of problem: Limitations and drawbacks associated with root canal obturation have the potential to impair periapical healing especially in the absence or delay of a proper coronal seal.
Aim of the study: Evaluate the endodontic treatment success in terms of resolution of signs and symptoms and periapical status using conventional periapical radiographs following two different treatment modalities, Coronally Sealed Non-obturated Canals, Regeneration-based Non-obturated Canals and comparing them to a control group of gutta percha obturated canals.
Materials and methods: Forty-eight Patients with mature, double canal, vital upper first premolars with irreversible pulpitis. In a single visit, the tooth is to be anesthetized, isolated and an access cavity is to be performed. Mechanical preparation of root canals is to be performed using the standardized technique reaching apical canal preparation to size #35 with taper of 4%. The patients will then be divided into three groups (n=16). Group One (Control group) will be conventionally obturated with gutta percha and resin sealer, and coronally sealed with glass ionomer and composite restoration. Group Two will be left unobturated and will receive a seal of MTA 2-3 mm below the CEJ then coronal restoration of glass ionomer and composite restoration. In Group Three, an induction of bleeding will be performed by apical violation and the tooth will receive a seal of MTA 2-3 mm below the CEJ then coronal seal of glass ionomer and composite restoration.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo, 이집트
- Faculty of Dentistry, Ain Shams University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Males.
- Age: 18-50 years.
- Medically free.
- Vital, mature upper first premolars with irreversible pulpitis.
- Adequate coronal tooth structure.
- Compliant patients.
Exclusion Criteria:
- Generalized periodontitis.
- Females.
- Vertical root fracture.
- Immature teeth.
- Necrotic teeth.
- Systemic diseases that affect healing process.
- Non restorable teeth.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Conventional root canal treatment
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The canals were dried with paper points, obturated using gutta percha and resin sealer utilizing the warm vertical compaction obturation technique.
The backfilling of the canal stopped at 3mm below canal orifice.
Followed by an MTA coronal plus and glass ionomer and composite restoration.
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|
활성 비교기: Regeneration group
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The canals were be dried with paper points, and intentional over-instrumentation past the apical foramen into the periapical tissues was performed to induce bleeding inside the canal, to provide the blood clot that will act as a scaffold into which locally residing stem cells can get seeded and the cascade of healing process can initiate.
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활성 비교기: Cleaning and Shaping only
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The canals were dried with paper points, left unobturated and received MTA coronal plug 2-3 mm below CEJ then sealed coronally with Glass ionomer filling and composite restoration.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Resolution of signs and symptoms. (Clinical Assessment) (VAS)(Visual Analogue Scale) No pain on percussion or palpation, absence of swellings and sinus tracts.
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Absence of periapical pathosis. (Periapical status in a conventional 2D periapical radiograph) (Periapical index PAI)
기간: 12 months
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12 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- FDASU-RECM012384
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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