- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07861659
Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
The aim of this study is to clinically evaluate the performance of 3D-printed composites compared to direct conventional composite restorations in Class II cavities
연구 개요
상태
상세 설명
Resin-based composites are widely used for posterior restorations because of their esthetics, adhesion, and conservative preparation. However, Class II restorations remain challenging due to polymerization shrinkage, marginal gaps, postoperative sensitivity, and inadequate proximal contacts. Digital additive manufacturing has emerged as a promising approach, offering precise fabrication, reduced material waste, and customizable restorations. Although laboratory studies suggest favorable mechanical properties and marginal adaptation, clinical evidence for 3D-printed intracoronal restorations remains limited. Therefore, this randomized clinical trial will compare the clinical performance of 3D-printed composite inlays with conventional direct composite restorations in Class II cavities over 24 months.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Egypt
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Tanta, Egypt, 이집트, 31511
- aculty of Dentistry, Tanta University, Tanta, Tanta 31527
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have at least two Class II carious lesions corresponded to ICDAS scores 4 and 5, representing dentinal caries suitable for operative restorative treatment.
- The absence of ongoing orthodontic treatment or use of prostheses.
- Good general health without relevant disease.
Exclusion Criteria:
- Uncooperative patient.
- Any parafunctional habits such as tooth clenching or grinding.
- Chronic pulmonary diseases and blocked nasal passages.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 3D-Printed Composite Inlays
Participants will receive Class II restorations fabricated from a commercially available 3D-printable permanent composite resin using a standardized digital workflow. The restorations will be adhesively bonded to the prepared cavities according to the manufacturer's instructions. |
Class II cavities will be restored with digitally designed and 3D-printed permanent composite inlays. The restorations will be post-cured and adhesively cemented according to the material manufacturer's recommendations |
|
활성 비교기: Direct Composite Restorations
Participants will receive conventional direct Class II restorations using a commercially available resin-based composite. Restorations will be placed incrementally using a standardized adhesive protocol and light-curing procedure according to the manufacturer's recommendations. Both groups will be clinically evaluated at baseline and during the 18-month follow-up period using standardized clinical criteria. |
Class II cavities will be restored directly using a conventional light-cured resin-based composite placed with a standardized incremental technique and adhesive protocol |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fracture and retention
기간: 18 months
|
Description: Clinical evaluation of fracture and retentin was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was evaluated according to the degree of conformity with the established criteria as follows: score 1, excellent; scores 2 and 3, satisfactory; and scores 4 and 5, inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure. |
18 months
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Balestra D, Lowther M, Goracci C, Mandurino M, Cortili S, Paolone G, Louca C, Vichi A. 3D Printed Materials for Permanent Restorations in Indirect Restorative and Prosthetic Dentistry: A Critical Review of the Literature. Materials (Basel). 2024 Mar 18;17(6):1380. doi: 10.3390/ma17061380.
- Duarte S Jr, Phark JH. Advances in Dental Restorations: A Comprehensive Review of Machinable and 3D-Printed Ceramic-Reinforced Composites. J Esthet Restor Dent. 2025 Jan;37(1):257-276. doi: 10.1111/jerd.13371. Epub 2024 Nov 18.
- Tanaka LEB, da Silva Rodrigues C, Grangeiro MTV, Campos TMB, de Melo RM. Characterization of 3D printed composite for final dental restorations. Clin Oral Investig. 2024 Oct 31;28(11):617. doi: 10.1007/s00784-024-06003-8.
- Peskersoy C, Oguzhan A. Evaluation of the Mechanical and Adhesion Characteristics of Indirect Restorations Manufactured with Three-Dimensional Printing. Polymers (Basel). 2024 Feb 23;16(5):613. doi: 10.3390/polym16050613.
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
- 3D-Printed & Direct Composite
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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