Effectiveness of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces of Primary and Permanent Molars in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 546
- 试验地点
- 2
- 主要终点
- Sealants clinical efficacy
研究概览
简要总结
The aim of this study is to evaluate the efficacy of oral hygiene orientation singly, compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups: oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and 12 months regarding clinical and radiographic lesions progression. The costs and cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction and impact on quality of life will also be investigated. Poisson regression analysis will be performed in order to compare the groups, through clinical and radiographic criteria. This test will also be used to assess the association between the group and patient discomfort and parents' satisfaction. Time, costs and impact on quality of life of the treatments will be compared by Student's t test. For all analyses, the significance level will be set at 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •parents or legal guardians accept and sign the informed consent form.
- •children must have at least one molar with caries lesion classified as ICDAS active score 3.
排除标准
- •children with special needs and/or systemic diseases with oral impairment.
- •teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, cavitated caries lesions in dentin or other types of formation defects.
结局指标
主要结局
Sealants clinical efficacy
时间窗: Every 6 months up to 12 months
The clinical evaluation will be performed by one blinded examiner. If the surface is sealed, the examiner will classify it according to described by Pardi et al. (2005); if the surface is without material, the examiner will use the International Caries Detection and Assessment System (ICDAS) criteria (Ismail et al., 2007).
Sealants radiographic efficacy
时间窗: Every 6 months up to 12 months
The radiographic evaluation will be performed by two blinded examiners, which will evaluate the four patients' radiographies independently, two by two, without knowing the chronological order of them. The efficacy of the treatment will be related to the presence or absence of increasing radiolucent area. They will also classify each radiograph using Ekstrand criteria (Ekstrand et al., 1997) and analyze them in a software (ImageJ 1.49, National Institute of Health, United States of America) in order to make the radiographic subtraction.
次要结局
- Parents' reported satisfaction with treatment(6 months)
- Children self-reported discomfort(Baseline)
- Sealants cost-efficacy(Through study completion (12 months))
- Sealants and oral hygiene orientation costs(Baseline)
- Impact on children's quality of life of sealants or oral hygiene orientation(6 and 12 months)
研究者
Jose Carlos P Imparato
PhD, Senior Lecturer
Faculty Sao Leopoldo Mandic Campinas