Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Colour matching
研究概览
简要总结
The goal of this observational study is to evaluate the clinical performance of a single-shade composite resin, used with an injection moulding technique, in restoring maxillary incisors affected by traumatic dental injury in patients aged 6-15 years.
The main questions it aims to answer are:
- How well does a single composite resin colour match the natural tooth?
- How stable is the colour over a 6- and 12-month follow-up?
- How satisfied are the children and parents with the restoration?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who exhibit cooperative dental behaviours (rating 3 and 4) according to Frankl's behaviour rating scale (Frankl et al. 1962)
- •Presence of at least one maxillary anterior permanent tooth with one-third of crown structure loss from dental trauma
- •The affected tooth must be vital or have undergone vital pulp therapy (e.g., pulpotomy with Calcium hydroxide, white-MTA, or Biodentine)
排除标准
- •Known allergy to methacrylate-based materials
- •Presence of parafunctional habits, such as bruxism
- •Presence of rampant caries
- •Presence of signs of hypomineralisation, such as post-eruptive breakdown, hypersensitivity, changes in enamel texture and hardness, and abnormal translucency on radiographs.
- •The affected tooth is classified as having moderate or severe discolouration according to Dean's fluorosis index (Dean, 1942)
- •The affected tooth has lost less than one-third of its coronal crown structure
- •The affected tooth has a fracture located at the subgingival margin
- •The affected tooth requires splinting due to the severity of the trauma
- •Presence of severe malocclusion that could compromise the integrity of the restoration
结局指标
主要结局
Colour matching
时间窗: Immediate, 1-week, 6-month, 12-month after restoration
Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency.
Colour stability
时间窗: 1-week, 6-month, 12-month after restoration
Colour match and translucency, surface and margin staining, and surface lustre grading of 'very good' according to FDI criteria indicates clinically excellent colour stability.
次要结局
- Patient satisfaction(1-week, 6-month, 12-month after restoration)
- Parent satisfaction(1-week, 6-month, 12-month after restoration)
研究者
Sawanya Prutthithaworn
Principal Investigator
Mahidol University