Clinical Evaluation of Direct and Indirect Restorations in Class I Cavities: A 10-Year Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- 10-Year Clinical Success Rate of Direct and Indirect Restorations
研究概览
简要总结
This clinical study aims to evaluate and compare the long-term clinical performance of direct and indirect restorations in Class I cavities of molar teeth over a 10-year period. A total of 54 restorations (27 direct and 27 indirect) were placed in 27 patients, with each patient receiving one direct and one indirect restoration. The restorations were evaluated at baseline, and at 1-, 2-, and 10-year follow-ups using modified USPHS criteria.
详细描述
This prospective clinical study was designed to evaluate and compare the long-term clinical performance of direct and indirect composite restorations in Class I cavities of permanent molar teeth over a 10-year period.
A total of 27 patients were enrolled in the study. Each participant received one direct and one indirect restoration, resulting in a total of 54 restorations (27 direct and 27 indirect).
Direct restorations were performed intraorally using a microhybrid composite and adhesive system in accordance with the manufacturer's instructions. Indirect restorations were fabricated in the laboratory using a reinforced microfill composite system and cemented using resin cement.
All restorations were clinically evaluated at baseline, and at 1-, 2-, and 10-year follow-up appointments. The modified United States Public Health Service (USPHS) criteria were used for evaluation. The assessed parameters included surface texture, anatomic form, color match, marginal adaptation, cavosurface marginal discoloration, and the presence of caries.
The aim of this study is to provide evidence-based clinical data regarding the durability and performance of direct and indirect composite restorations in posterior teeth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting with two Class I cavities
- •Good oral hygiene maintenance
- •Absence of pulp or periodontal disease
- •Requirement for restoration of permanent molars due to occlusal caries
排除标准
- •Presence of parafunctional habits (e.g., bruxism or clenching)
- •Poor oral hygiene
- •Lack of interest in or refusal to comply with oral hygiene instructions
- •Pulp exposure during caries removal
- •Percussion sensitivity indicating possible pulpal or periapical pathology
- •Spontaneous discomfort associated with periodontal disease
结局指标
主要结局
10-Year Clinical Success Rate of Direct and Indirect Restorations
时间窗: 10 years
The primary outcome is the clinical success rate of direct and indirect Class I restorations in molar teeth after 10 years. Success and failure were assessed using modified United States Public Health Service (USPHS) criteria. A restoration was considered a failure if it required replacement due to secondary caries or other clinical complications.
次要结局
未报告次要终点
研究者
Neslihan Tekçe
Professor Dr.
Kocaeli University