- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07705633
Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Resin Restorations
Clinical Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Preventive Resin Restorations
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Primary objectives:
Assessment of retention rate and marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria and Simonsen's criteria.
Secondary objectives:
Assessment of stability of results after 3, 6 and 9months.
연구 개요
상태
개입 / 치료
- 장치: Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid
- 장치: Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste
- 장치: Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid
- 장치: Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
상세 설명
Dental caries is one of the most common intraoral diseases, with serious consequences for both the individual patient and for the public in terms of medical, social, and economic concerns. The individual patient suffers from pain, dysfunction of the oral system, and reduced quality of life.
Caries predominantly attack the occlusal surfaces of premolars and molars during their eruption . On the other hand, smooth surface caries have shown a significant decline, likely a result of increased worldwide access to fluoride . In previous reports, an incomplete post-eruptive maturation , and the presence of narrow and deep fissures were blamed for the increased caries susceptibility of occlusal surfaces . It has been more than 40 years since the pit and fissure sealants were first used clinically. During this time, pit and fissure sealants have been shown to be effective in reducing the risk of occlusal caries . A study aimed to evaluate the effect of the previous application of a casein phosphopeptide-amorphous calcium phosphate paste (MI Paste, MI) and adhesive systems on the bond durability of a fissure sealant. Ninety-eight enamel blocks were obtained from proximal surfaces of erupted third molars.
Anthor study evaluated the effect of treating the enamel with topical fluoride gel prior to acid etching on sealant retention clinically (Part I) and in vitro (Part II). Results showed no statistically significant differences between the test and control groups either clinically or in vitro. It is concluded that topical fluoride application prior to acid etching does not have a deleterious effect on sealant retention .
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Suez, 이집트
- Suez Canal University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Absence of restorations or prior sealants on the teeth under study.
- Patients have simple occlusal spot caries lesions
- Age group 15 - 40 years.
- Ability to return for periodic follow-up
Exclusion Criteria:
- Patients with high DMFS.
- Any fixed orthodontic appliances.
- Smoking habit.
- Pregnant and lactating mothers
- Symptoms of dental pain
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
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Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
|
|
실험적: Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
|
장치: Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste
Group 2 (G2): Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
|
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실험적: prevent seal, Itena, North America after treating with Biflourid Group
Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
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Group 3 (G3): Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
|
|
실험적: prevent seal, Itena, North America after treating with MI Paste Group
Teeth treated with prevent seal, Itena, North America after treating with MI Paste, GC AmericaC America
|
Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Retention rate of two types of pit and fissure sealants
기간: After 3 months, 6 months and 9 months
|
Assessment of retention rate of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
|
After 3 months, 6 months and 9 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
marginal integrity assessments
기간: After 3 months, 6 months and 9 months.
|
Assessment of marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
|
After 3 months, 6 months and 9 months.
|
공동 작업자 및 조사자
스폰서
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
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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