Two-year Clinical Evaluation of Different Indirect Tooth-colored Onlay Restorations Placed in Posterior Teeth With Cervical Margin Relocation and Laboratory Investigation of Marginal Adaptation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains.
研究概览
简要总结
This study will evaluate the performance of three different tooth-colored onlay materials in adult patients' posterior teeth. First, investigators will use a bulk-fill composite resin to raise the cavity margin above the gum line and below the contact point. Then each patient will receive three onlays made from different materials. Investigators will follow patients at 2 weeks, 6 months, 18 months, and 24 months to assess how well the onlays fit, function, and whether restorations cause sensitivity or new decay. The results will help dentists choose the most durable onlay restorations for deep-margin elevation cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Molar tooth with proximal subgingival carious lesion of ICDAS 4 or 5, causing weakening of one or more cusps.
- •Normal alignment with the adjacent and opposing teeth.
- •Acceptance of the follow-up period and recall visits for 2 years.
排除标准
- •Distance between the gingival margin and the crestal bone < 2 mm.
- •The tooth would require direct pulp capping.
- •Poor oral hygiene (or not completing the oral hygiene phase).
- •Chronic periodontitis.
- •Pulpitis or non-vital tooth.
- •Orthodontic treatment.
- •Parafunctional habits.
- •Systemic disease.
- •Teeth act as abutment for fixed or removable prosthesis.
- •Occlusion of fewer than 20 teeth
研究组 & 干预措施
Machinable lithium-disilicate ceramic onlay (IPS e.max CAD)
Each participant contributes one randomized molar restored with a machinable lithium-disilicate onlay (IPS e.max CAD). Adhesive luting is performed under rubber-dam isolation using the standardized protocol.
干预措施: Machinable lithium-disilicate ceramic onlay (IPS e.max CAD) (Other)
Pressed lithium-disilicate ceramic onlay (IPS e.max Press)
Each participant contributes one randomized molar restored with a pressed lithium-disilicate onlay (IPS e.max Press). Adhesive luting is performed under rubber-dam isolation using the standardized protocol.
干预措施: Pressed lithium-disilicate ceramic onlay (IPS e.max Press) (Other)
Machinable composite onlay (BRILLIANT Crios)
Each participant contributes one randomized molar restored with a machinable composite onlay (BRILLIANT Crios). Adhesive luting is performed under rubber-dam isolation using the standardized protocol.
干预措施: Machinable composite onlay (BRILLIANT Crios) (Other)
结局指标
主要结局
FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains.
时间窗: Post-cementation baseline (2 weeks), 6, 12, 18, and 24 months
Each onlay will be scored per the Revised 2023 World Dental Federation (FDI) criteria across the specified domains (F1, F2, B1, B2, B3, M2). Outcomes will be summarized as (a) mean (SD) score for each domain, and (b) proportion of restorations rated 1-3 (clinically acceptable) vs 4-5 for each domain. Lower scores indicate better clinical performance.
次要结局
未报告次要终点