- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07689032
Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth: A 24-Month Randomized Clinical Trial
연구 개요
상세 설명
The rationale for this 24-month RCT is driven by the need for high-level, evidence-based data to guide clinical material selection for compromised teeth. This trial is designed to directly compare two materials specifically engineered to be stress-absorbing in the oral environment. The primary intervention, the SHOFU Restorative System (Hard blocks), is a Hybrid Ceramic engineered to combine the durability of ceramics with the elasticity of polymers. Its reduced hardness and dentin-like modulus allow for rapid machining and are associated with reduced antagonist abrasion compared to conventional ceramics. The second material, serving as the comparator, is the Coltène Restorative System (BRILLIANT Crios), which is a reinforced nano-hybrid composite characterized by an elastic modulus comparable to dentin, designed for optimal shock absorption and confirmed to be gentle on antagonist teeth.
Focusing the study on endodontically treated molars addresses a highly prevalent clinical scenario where maximizing the longevity of the restoration and the remaining tooth structure is paramount. The use of a full-cusp-coverage overlay design represents the maximum conservation approach for these compromised teeth while ensuring that the selected restorative materials do not exert harmful effects on opposing dentition.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 22 and 45 years.
- Low to moderate caries risk.
- Normal occlusion.
- Absence of signs or symptoms of temporomandibular joint (TMJ) disorders.
- Satisfactory oral hygiene.
- Medically fit to receive routine restorative dental treatment.
- Permanent molars.
- Asymptomatic endodontically treated teeth.
- Homogeneous root canal fillings extending 1-2 mm from the radiographic apex.
- Compound cavities.
- Favorable occlusion.
- Presence of both an adjacent tooth and a sound opposing tooth in occlusion
Exclusion Criteria:
* Presence of bruxism.
- Poor patient cooperation.
- Inability or unwillingness to attend follow-up appointments.
- Anticipated travel during the study period.
- Poor oral hygiene.
- Chronic or advanced periodontitis.
- Known allergies to any of the materials used in the study.
- Patients who are pregnant or breastfeeding.
- Teeth with <1" mm" of residual wall thickness.
- Deep subgingival cavity margins.
- Severe periodontal problems.
- Radiographic signs of apical pathology.
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 |
|---|---|
|
실험적: SHOFU Hard blocks
CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.
|
CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.
|
|
활성 비교기: BRILLIANT Crios
Resin-based Composite, Overlay restored using the Coltène cementation system.
|
Resin-based Composite, Overlay restored using the Coltène cementation system.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Annual wear rate
기간: 24 months
|
Digital Scanner +Geometrical Subtraction Software
|
24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional properties, Biological properties and Esthetic properties
기간: 24 months
|
FDI Criteria
|
24 months
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 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. .