Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Need of reintervention
研究概览
简要总结
This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.
详细描述
This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment.
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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They will be included in this study children:
- •aged 3 years and 6 years and 11 months;
- •With complete primary dentition;
- •Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars surfaces.
- •Who have assented to participate and whose parents have consented to their participation by signing the Instrument of Consent.
排除标准
- •who have medical and / or behavioral conditions that require special considerations regarding handling / treatment;
- •who are involved in other research that may impact on this study;
- •whose parents that not agree in participate.
研究组 & 干预措施
restoration - control
Restoration
干预措施: Ionomer Restoration (control) (Procedure)
restoration - control
Restoration
干预措施: Oral hygiene orientation and professional fluoride application (Procedure)
sealant - test
Sealant
干预措施: Ionomer Sealant (test) (Procedure)
sealant - test
Sealant
干预措施: Oral hygiene orientation and professional fluoride application (Procedure)
结局指标
主要结局
Need of reintervention
时间窗: 24 months
Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline. After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included.
次要结局
- Child's reported discomfort(1st day)
- Duration of treatments(1st day)
研究者
Mariana Minatel Braga
PhD, Associate Professor
University of Sao Paulo