Repair Versus Replacement of Failed Restorations in Primary Teeth: Protocol for a Non-Inferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Restoration survival
研究概览
简要总结
Dental caries affect approximately 573 million children globally, and the management of failed restorations is a frequent clinical issue in pediatric dentistry. Although complete replacement of restorations is traditionally the most commonly adopted approach, repair represents a minimally invasive alternative that preserves healthy dental structure and reduces the risk of pulpal complications. Studies in permanent teeth demonstrate that repair may present longevity similar to replacement; however, there is no robust evidence regarding this comparison in primary teeth. This randomized controlled clinical trial, with parallel groups and a 1:1 allocation ratio, aims to evaluate the non-inferiority of repair compared with replacement of failed restorations in primary molars, using encapsulated high-viscosity glass ionomer cement. Children aged 4 to 8 years with at least one failed restoration eligible for repair in primary molars will be included. Randomization will be stratified by number of surfaces. Teeth (n=824) will be randomly allocated to one of the groups: repair or replacement. The primary outcome will be restoration survival at 24 months. Cost-effectiveness will be evaluated as a secondary outcome. Statistical analysis will use Kaplan-Meier curves and Cox regression with shared frailty (¿=5%).
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
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 8 years;
- •Presence of at least one defective restoration in a primary molar, involving no more than 3 surfaces;
- •Absence of clinical and radiographic signs of pulp involvement;
排除标准
- •Tooth without pulp vitality or requiring endodontic treatment;
- •Loose or mobile restoration;
- •Presence of fistula, abscess, or history of pain;
- •Tooth mobility incompatible with the physiological exfoliation timeline;
- •Parents/guardians who do not consent to participation by signing the ICF, or children who do not assent to participate in the study.
研究组 & 干预措施
Repair
Repair of Failed restoration in primary teeth.
干预措施: Repair of Failed Restoration (Procedure)
Replacement
Replacement of Failed Restoration in primary teeth.
干预措施: Replacement of Failed Restoration (Procedure)
结局指标
主要结局
Restoration survival
时间窗: 24 months
Restoration survival will be assessed based on clinical evaluation of the restorations at 6, 12, 18, and 24 months. A restoration will be considered to have survived when it remains clinically satisfactory according to the following criteria. Single-surface restorations will be considered satisfactory when scored as 0 (restoration present and satisfactory), 1 (restoration present, with a slight marginal defect and/or surface wear of less than 0.5 mm in depth, with no need for repair), or 7 (restoration present, with gradual wear involving larger areas of the restoration but less than 0.5 mm in depth at the deepest point, with no need for repair), according to Frencken et al. (1996). Multiple-surface restorations will be considered satisfactory when scored as 00 (restoration present and satisfactory) or 10 (restoration present, with a slight marginal defect and/or surface wear of less than 0.5 mm in depth, with no need for repair), according to Rôlevald et al. (2006).
次要结局
- Treatment success(24 months)
- Parents' and Child's Preference(Before randomization and prior to treatment)
- Treatment Time(From the beginning to the completion of the treatment procedure)
- Child's Perception(Immediately after the procedure (Day 0))
- Parents'/Guardians' Satisfaction(Immediately after the procedure (Day 0))
- Parents'/Guardians' Willingness to Choose the Treatment Again(30 days after the procedure)
- Cost-effectiveness(24 months)
- Treatment Cost(Immediately after the procedure (Day 0))
研究者
Tamara Kerber Tedesco
Assistant Professor
University of Sao Paulo