The Impact of Adhesion Strategy on the Clinical Performance Of Indirect Dental Restorations
The Influence of Cement Systems on the Outcome of Tooth Supported Zirconia Crowns in the Posterior Region: a Randomized ,Multicenter, and Practice-based Clinical Trial
The goal of this clinical trial is to evaluate whether different cement systems influence the clinical outcome of posterior tooth supported zirconia crowns in adult patients requiring single crown restorations. The main questions it aims to answer are:
- Do glass ionomer cements provide clinical outcomes comparable to those of resin cements for posterior zirconia crowns?
- Do marginal discoloration, marginal integrity, and biological complications differ between the cement systems?
- Do patient reported and clinician reported outcomes differ between the cementation procedures?
Researchers will compare zirconia crowns cemented with either a glass ionomer cement or a resin cement to evaluate differences in clinical outcomes.
Participants will:
- Receive posterior zirconia crowns fabricated according to standardized clinical procedures
- Be randomized to cementation with either a glass ionomer cement or a resin cement
- Undergo clinical examinations assessing crown survival, marginal adaptation, discoloration, caries, periodontal status, and wear
- Complete questionnaires regarding patient comfort and treatment experience
- Attend baseline and annual follow-up examinations for up to 10 years
연구 개요
상세 설명
Tooth damage has significant impact on a person's quality of life and damaged teeth should be treated to restore lost functions and prevent further damage. Loss of tooth substance can be restored by a direct (filling) or indirect restoration (artificial crown). These interventions differ in some operative aspects but share key challenges, particularly in achieving optimal adhesion to tooth substance to secure predictable retention and the integrity of the marginal seal.
Failure of the adhesive interface is a major determinant of restoration longevity and may manifest across patient-centered, biological, and technical outcomes.
Marginal degradation may result in discoloration, representing an early clinical indicator of interface breakdown that negatively affects patient satisfaction and may lead to a need for retreatment. Progressive marginal leakage facilitates bacterial access, increasing the risk of biological complications such as secondary caries and pulpal involvement.
Loss of retention represents a major technical complication, often requiring replacement of the restoration and contributing to cumulative loss of tooth structure over time.
Despite advances in restorative materials and adhesive systems, clinical outcomes remain variable, and the relative contribution of material properties, procedural complexity, and biological factors to long-term failure is not fully understood. In particular, the role of technique sensitivity and procedural complexity as independent determinants of restoration survival remains insufficiently characterized. Improved understanding of these interacting factors will enable more precise selection of restorative materials and cementation strategies.
This project will: (a) identify and quantify clinically relevant determinants of restoration failure, enabling improved prediction of restoration survival and patient satisfaction, (b) elucidate how interfacial degradation and technique sensitivity contribute to biological and technical complications, (c) aid clinical decision-making by guiding selection of materials and procedures based on their performance and complexity.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Skåne County
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Hörby, Skåne County, 스웨덴
- Sandin Dentalklinik
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Malmö, Skåne County, 스웨덴, 21118
- Tandläkare Le
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Need of one single crown on vital posterior tooth
- Speak and understand Swedish language
- Free from dental/oral disease; caries, periodontal disease
Exclusion Criteria:
- Only individuals who do not meet the inclusion criteria will be excluded.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Resin cement
Tooth-supported zirconia crowns cemented with a resin-based cement
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Zirconia crowns cemented with resin cement
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활성 비교기: Glass-ionomer cement
Tooth-supported zirconia crowns cemented with a glass-ionomer cement
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Zirconia crowns cemented with glass-ionomer cement
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up
기간: Baseline and 1 year.
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Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
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Baseline and 1 year.
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Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up
기간: Baseline and 3 years.
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Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
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Baseline and 3 years.
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Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up
기간: Baseline and 5 years.
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Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
|
Baseline and 5 years.
|
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Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up
기간: Baseline and 10 years.
|
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
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Baseline and 10 years.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in "Patient-reported Outcome Measurement" at 1 year
기간: Baseline and 1 year.
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Patient reported and operator reported outcomes will be assessed using structured questionnaires evaluating treatment comfort, clinical handling, and overall satisfaction.
Questionnaire scores range from 1 to 5, where higher scores indicate greater satisfaction and improved treatment experience.
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Baseline and 1 year.
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Change from Baseline in "Patient-reported Outcome Measurement" at 3 year
기간: Baseline and 3 year.
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Patient reported and operator reported outcomes will be assessed using structured questionnaires evaluating treatment comfort, clinical handling, and overall satisfaction.
Questionnaire scores range from 1 to 5, where higher scores indicate greater satisfaction and improved treatment experience.
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Baseline and 3 year.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Christel Larsson, Ph.D., Malmö 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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-03170-01
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
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. .
건강한 성인 참가자에 대한 임상 시험
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Vigil Neuroscience, Inc.종료됨ALSP미국, 브라질, 캐나다, 독일, 네덜란드, 영국
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin모병부신백질이영양증 | 부신척수신경병증 | 이색성 백질이영양증 | Axonal Spheroids와 Pigmented Glia를 동반한 Adult-Onset Leukoencephalopathy프랑스
Resin cement에 대한 임상 시험
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Hadassah Medical Organization정지된
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Faculty Sao Leopoldo Mandic Campinas알려지지 않은
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Repolar Pharmaceuticals OyPrinceton Consumer Research완전한
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Ege University모집하지 않고 적극적으로충치 | 치아 탈회 | 법랑질에 국한된 매끄러운 표면의 충치 | 치과, 수술 | 충치 활동 테스트 | 캐리오그램칠면조