Clinical and Radiographic Evaluation of Composite Resin Restorations and Computer-Aided Restorations in Young Permanent Molar Teeth With Molar Incisor Hypomineralization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Clinical evaluation (Modified USPHS criteria-Surface roughness)
研究概览
简要总结
Aim: This randomized controlled clinical study aimed to compare direct composite resin restorations and Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) supported inlay or onlay restorations in young permanent molar teeth with hypomineralization.
The main questions aim to answer are:
- The clinical success rate of CAD-CAM supported restorations
- The highest clinical success rate for restoring hypomineralized teeth.
Materials and method: Children aged 6-14 years old without any systemic conditions with 32 first and second hypomineralized permanent molar teeth were included in the study. Patients were randomly distributed into 2 groups as direct composite resin restorations and CAD-CAM supported inlay or onlay restorations. All restored teeth were evaluated clinically and radiographically for 24-months. Statistical significance was accepted as p<0.05.
详细描述
After randomization and local anesthesia administration, caries removal and preparation were completed under rubber-dam isolation. After preparation, 60 seconds of orthophosphoric acid, 60 seconds of 5% sodium hypochlorite and 30 seconds of orthophosphoric acid steps were applied before bonding agent and composite resin restorations. On the other hand, the preparation was completed by making a bevel on the enamel surfaces and a nanohybrid ceramic material used for the manufacturing CAD-CAM supported inlay or onlay restorations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with first and second permanent molar teeth that have loss of more than one surface due to hypomineralization and seen with white, brown, or yellow opacities on anterior permanent teeth
- •Patients without any systemic, physical, physiological, or allergic conditions
排除标准
- •Patients who had symptoms during the follow-up periods
- •Patients who did not attend follow-up appointments
结局指标
主要结局
Clinical evaluation (Modified USPHS criteria-Surface roughness)
时间窗: 24 months
Surface roughness was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Secondary caries)
时间窗: 24 months
Secondary caries was examined by inspection and probing at 3,6,12,18, and 24 months.
Radiographical evaluation (Radiolucent area development)
时间窗: 24 months
Radiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Clinical evaluation (Modified USPHS criteria- Anatomic form)
时间窗: 24 months
Anatomic form was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal discoloration)
时间窗: 24 months
Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Retention)
时间窗: 24 months
Retention was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal adaptation)
时间窗: 24 months
Marginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Color stability)
时间窗: 24 months
Color stability was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Proximal contact)
时间窗: 24 months
Proximal contact was examined by inspection and probing at 3,6,12,18, and 24 months.
Radiographical evaluation (Lamina dura)
时间窗: 24 months
Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Radiographical evaluation (Change in inter-root trabeculation continuity)
时间窗: 24 months
Change in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
次要结局
未报告次要终点