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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Skåne County
-
Hörby、Skåne County、スウェーデン
- Sandin Dentalklinik
-
Malmö、Skåne County、スウェーデン、21118
- Tandläkare Le
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Resin cement
Tooth-supported zirconia crowns cemented with a resin-based cement
|
Zirconia crowns cemented with resin cement
|
|
アクティブコンパレータ：Glass-ionomer cement
Tooth-supported zirconia crowns cemented with a glass-ionomer cement
|
Zirconia crowns cemented with glass-ionomer cement
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up
時間枠：Baseline and 1 year.
|
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 1 year.
|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up
時間枠：Baseline and 3 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.
|
Baseline and 3 years.
|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up
時間枠：Baseline and 5 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.
|
Baseline and 5 years.
|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up
時間枠：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.
|
Baseline and 10 years.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in "Patient-reported Outcome Measurement" at 1 year
時間枠：Baseline and 1 year.
|
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.
|
Baseline and 1 year.
|
|
Change from Baseline in "Patient-reported Outcome Measurement" at 3 year
時間枠：Baseline and 3 year.
|
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.
|
Baseline and 3 year.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Christel Larsson, Ph.D.、Malmö University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-03170-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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