Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates: A 12-Month Parallel Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Surface luster
研究概览
简要总结
Esthetic restoration of primary anterior teeth is challenging. Aim of the study: Evaluation of the 12-month clinical performance of direct resin composite restoration of carious vital primary anterior teeth using custom 3D printed templates compared to conventional strip crowns. Subjects and methods: A parallel arms randomized controlled clinical trial was performed in which 98 carious vital primary anterior teeth in 32 children were directly restored with resin composite either with the help of custom 3D printed templates (Group: A) or strip crowns (Group: B). Restorations were assessed for surface luster, anatomical form, material fracture, marginal adaptation, and periodontal response using the revised FDI criteria on three occasions; a week after placement (T0), after six months (T1), and after twelve months (T2). Comparisons between groups were evaluated. A statistically significant level was considered when p value less than or equal 0.05. The tooth was the unit of analysis.
详细描述
The present study is a single-center randomized controlled clinical trial with 1:1 allocation ratio. This trial entailed directly restoring carious primary anterior teeth with resin composite either with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models (Group: A) or conventional strip crowns (Group: B). Restorations were assessed for clinical performance on three occasions; postoperatively (T0), after six months (T1), and after twelve months (T2).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least two vital carious primary maxillary incisors.
- •Teeth had at least two carious surfaces requiring complete coronal restoration.
排除标准
- •Children with malocclusion or parafunctional oral habits
- •Teeth beyond restoration.
结局指标
主要结局
Surface luster
时间窗: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Anatomical form
时间窗: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Material fracture
时间窗: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Marginal adaptation
时间窗: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Periodontal response
时间窗: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
次要结局
未报告次要终点
研究者
Mina Kamal Yassa
Lecturer in Paediatric and Community Dentistry Department, Faculty of Dentistry, Minia University, Minia, Egypt.
Minia University