- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07627295
Impact of Finishing/Polishing Systems on Ormocer VS Methacrylate Based Bulk Fill Flowable Composite in Class V
Impact of Finishing/Polishing Systems on Ormocer Versus Methacrylate Based Bulk Fill Flowable Composite in Class V Restorations: Clinical Study and Laboratory Investigations
The goal of this clinical trial is to evaluate and compare. Impact of finishing/polishing systems on ormocer versus methacrylate-based bulk-fill flowable composite in Class V restorations: The main question it aims to answer is the following:
Are there any differences between finishing/polishing systems on Ormocer versus methacrylate-based bulk-fill flowable composite?
연구 개요
상태
정황
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: doha m zahran, master
- 전화번호: 00201026336671
- 이메일: dohazahran96@gmail.com
연구 연락처 백업
- 이름: Maha Ebaya, PhD
- 전화번호: 00201003749266
- 이메일: mahaebaya@mans.edu.eg
연구 장소
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, 이집트, 35516
- 모병
- Faculty of Dentistry, Mansoura University
-
연락하다:
- doha zahran
- 전화번호: 0020126336671
- 이메일: dohazahran96@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Three pairs of buccal cervical supragingival carious lesions in anterior teeth
- Complete and normal occlusion
- Good oral hygiene
- Willingness to attend follow-up and recall visits for 2 years
Exclusion Criteria:
- Teeth requiring direct pulp capping
- Poor oral hygiene or failure to complete the oral hygiene phase
- Chronic periodontitis
- Pulpitis or non-vital teeth
- Current orthodontic treatment
- Presence of parafunctional habits
- Systemic diseases
- Previous or ongoing bleaching procedures
- Smoking patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Ormocer bulk-fill +one-step finishing/polishing system
Class V was restored with an ormocer-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.
|
• Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a one-step finishing and polishing system.
|
|
실험적: Ormocer bulk-fill + two-step finishing/polishing system
Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.
|
Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a two-step finishing and polishing system.
|
|
실험적: Ormocer bulk-fill + three-step finishing/polishing system.
Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.
|
Each Class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each Class V restoration will be subjected to a three-step finishing and polishing system.
|
|
실험적: Methacrylate bulk-fill + one-step finishing/polishing system.
Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.
|
• Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a one-step finishing and polishing system.
|
|
실험적: Methacrylate bulk-fill + two-step finishing/polishing system.
Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.
|
Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a two-step finishing and polishing system.
|
|
실험적: Methacrylate bulk-fill+ three-step finishing/polishing system.
Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.
|
Each Class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each Class V restoration will be subjected to a three-step finishing and polishing system.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin)
기간: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
|
According to the revised 2023 World Dental Federation (FDI) criteria for,
Unit of Measure: FDI |
Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Doha M Zahran, master, MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
- 연구 책임자: Maha Ebaya, PhD, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
- 연구 책임자: asmaa abd allah, PhD, Assistant Professor, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University
- 연구 의자: Abeer El-Embaby, PhD, Professor, Conservative Dentistry Department,Faculty of Dentistry, Mansoura University
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
- MD250825
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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