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Repair Versus Replacement of Failed Restorations in Primary Teeth

2026年9月4日更新者：Tamara Kerber Tedesco、University of Sao Paulo

Repair Versus Replacement of Failed Restorations in Primary Teeth: Protocol for a Non-Inferiority Randomized Clinical Trial

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%).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

382

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Tamara K Tedesco, PhD
电话号码：+5511954866622
邮箱：tamarakt@usp.br

学习地点

巴西
- São Paulo
  - São Paulo、São Paulo、巴西、05508-000
    - University of São Paulo, School of Dentistry
    - 接触：
      
      Tamara K Tedesco, PhD
      
      电话号码：+5511954866622
      
      邮箱：tamarakt@usp.br
    - 接触：
      
      Camila C Cabral, PhD
      
      电话号码：+5511996254588
      
      邮箱：camila.cabral@usp.br
    - 副研究员：
      
      Aline S Gusmão, DDS

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子

接受健康志愿者

不

描述

Inclusion Criteria:

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;

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Repair Repair of Failed restoration in primary teeth.	程序：Repair of Failed Restoration Prior to the procedure, when needed, local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be used, with relative isolation (cotton rolls and saliva ejector). The defective area will be clinically identified. When present, carious tissue will be selectively removed with hand instruments (dentin curettes) suited to the cavity, preserving as much of the intact original restoration as possible. If no hand instrument fits, the cavity will be enlarged with a small spherical diamond bur at high speed under cooling. The surface will be conditioned with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsed abundantly, and dried with cotton pellets. For proximal surfaces, a metal matrix and wedge will be placed before the GIC. The capsule will be activated, mixed for 10 s, inserted with an applicator, and adapted by digital pressure with petroleum jelly. Occlusion will be checked with articulating paper and adjusted; surface protection applied with petroleum jelly.
有源比较器：Replacement Replacement of Failed Restoration in primary teeth.	程序：Replacement of Failed Restoration Prior to the procedure, when needed, infiltrative local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be administered. Relative isolation will be used, with cotton rolls and a saliva ejector. Complete removal of the defective restorative material will be performed with spherical diamond burs at high speed under cooling, complemented by round burs at low speed to remove remaining restorative material. Selective removal of carious tissue, when present, will be carried out with hand instruments (dentin curettes) suited to the cavity, preserving soft or leathery dentin according to the depth of the lesion. The new restoration will then be placed following the same protocol described for the repair group: conditioning with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsing and removal of excess water; placement of a metal matrix and wedge, when needed; insertion of the GIC into the cavity; adaptation by digital pressure with petroleum jelly; occlusal adjustment; a

参与者组/臂

干预/治疗

实验性的：Repair

Repair of Failed restoration in primary teeth.

程序：Repair of Failed Restoration

Prior to the procedure, when needed, local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be used, with relative isolation (cotton rolls and saliva ejector). The defective area will be clinically identified. When present, carious tissue will be selectively removed with hand instruments (dentin curettes) suited to the cavity, preserving as much of the intact original restoration as possible. If no hand instrument fits, the cavity will be enlarged with a small spherical diamond bur at high speed under cooling. The surface will be conditioned with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsed abundantly, and dried with cotton pellets. For proximal surfaces, a metal matrix and wedge will be placed before the GIC. The capsule will be activated, mixed for 10 s, inserted with an applicator, and adapted by digital pressure with petroleum jelly. Occlusion will be checked with articulating paper and adjusted; surface protection applied with petroleum jelly.

有源比较器：Replacement

Replacement of Failed Restoration in primary teeth.

程序：Replacement of Failed Restoration

Prior to the procedure, when needed, infiltrative local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be administered. Relative isolation will be used, with cotton rolls and a saliva ejector. Complete removal of the defective restorative material will be performed with spherical diamond burs at high speed under cooling, complemented by round burs at low speed to remove remaining restorative material. Selective removal of carious tissue, when present, will be carried out with hand instruments (dentin curettes) suited to the cavity, preserving soft or leathery dentin according to the depth of the lesion. The new restoration will then be placed following the same protocol described for the repair group: conditioning with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsing and removal of excess water; placement of a metal matrix and wedge, when needed; insertion of the GIC into the cavity; adaptation by digital pressure with petroleum jelly; occlusal adjustment; a

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Restoration survival 大体时间：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).	24 months

次要结果测量

结果测量	措施说明	大体时间
Treatment success 大体时间：24 months	Treatment success at 24 months will be assessed as a binary outcome. All participants will be clinically evaluated at 24 months, and each treated tooth will be classified as either successful or unsuccessful. Treatment will be considered successful when the treated tooth requires no operative reintervention during the 24-month follow-up period and remains asymptomatic, according to the clinical criteria described above. Natural exfoliation of the treated tooth during the follow-up period will also be considered a successful outcome. Treatment failure will be defined as the need for operative reintervention due to disease progression or treatment failure, including endodontic treatment or extraction.	24 months
Parents' and Child's Preference 大体时间：Before randomization and prior to treatment	Before randomization, parents or guardians and the child will receive a standardized explanation of the two therapeutic approaches under investigation (replacement and repair of restorations). To aid comprehension, illustrative images generated by artificial intelligence will be presented, depicting each procedure in a standardized manner. Parents or guardians and the child will then be asked: "If you could choose, which treatment would you prefer?" Responses will be recorded as: replacement, repair, or no preference.	Before randomization and prior to treatment
Treatment Time 大体时间：From the beginning to the completion of the treatment procedure	The total treatment time will be measured by a research assistant using a digital stopwatch. Timing will start at the beginning of the clinical intervention and stop immediately after its completion. Time will be recorded and expressed in minutes (min).	From the beginning to the completion of the treatment procedure
Child's Perception 大体时间：Immediately after the procedure (Day 0)	The child's perception of the treatment will be assessed immediately after completion of the procedure using the Facial Image Scale (FIS). The scale will be presented by the research assistant, in the absence of the operator, in order to minimize the professional's influence on the response. The child will be asked to indicate the image that best represents how they felt during the treatment, following the question: "How did you feel during the treatment?" The FIS consists of five facial images ranging from a very happy to a very sad expression, allowing assessment of the child's acceptance of the experience.	Immediately after the procedure (Day 0)
Parents'/Guardians' Satisfaction 大体时间：Immediately after the procedure (Day 0)	Immediately after completion of the treatment, parents or guardians will answer the following question: "How satisfied are you with the treatment performed on your child?" The response will be recorded on a five-point Likert scale, ranging from very dissatisfied to very satisfied.	Immediately after the procedure (Day 0)
Parents'/Guardians' Willingness to Choose the Treatment Again 大体时间：30 days after the procedure	At 30 days after the procedure, parents or guardians will be presented again with illustrative images of the two therapeutic approaches, accompanied by the same standardized explanation used in the initial assessment. They will then be asked: "If you could choose again, which treatment would you choose for your child?" Responses will be recorded as repair, replacement, or no preference.	30 days after the procedure
Cost-effectiveness 大体时间：24 months	Additionally, a cost-effectiveness analysis will be conducted comparing the repair and replacement of defective restorations in primary molars over 24 months of follow-up. Restoration survival over this period will be used as the effectiveness measure for the economic analysis. The analysis will adopt the perspective of the Brazilian public health system and will consider only direct treatment costs.	24 months
Treatment Cost 大体时间：Immediately after the procedure (Day 0)	The direct costs associated with the repair and replacement of restorations will be compared, considering the clinical treatment time and materials actually used in each procedure. Treatment time will be measured by a research assistant who is not involved in performing the interventions and will be used to estimate the dental professional's labor cost based on the cost per hour of professional work. Material costs will be estimated based on the actual amount consumed during each procedure and the prices obtained from three quotations from different suppliers, with the mean value of the quotations used for cost calculation. Costs will be expressed in Brazilian reais (BRL), based on the prices prevailing during the study period.	Immediately after the procedure (Day 0)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Sao Paulo

调查人员

首席研究员：Camila C Cabral, PhD、University of Sao Paulo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月7日

初级完成 (估计的)

2029年4月1日

研究完成 (估计的)

2029年4月1日

研究注册日期

首次提交

2026年9月4日

首先提交符合 QC 标准的

2026年9月4日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

Repair Versus Replacement of Failed Restorations in Primary Teeth