Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With Low and Moderate Caries Risk: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Dental caries incidence - Change
研究概览
简要总结
Objectives: To assess the effectiveness of two recall intervals on dental caries incidence (primary outcome) in preschool children with low and moderate caries risk. The level of anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes) according to each interval will also be assessed. Methods: The sample will consist of 224 children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo. Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet on the recall of 12 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18 months.
详细描述
An examiner calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: the gingival bleeding index, dental plaque index, detection of caries and its activity according to the ICDAS (International Caries Detection and Assessment System) and the clinical features of active and inactive caries lesions will be associated with the criteria discribed in ICDAS Commitee manual. An external dentist will conduct the assessment of the anxiety levels assessed by the Facial Image Scale, the OHRQoL measured by B-ECOHIS (Brazilian Early Childhood Oral Health Impact Scale), the time and costs. All groups will be followed for a period of 36 months. All analyzes will be performed with the intention of treatment (ITT) and considering the sensitivity analyzes to assess the differences between the ITT analyzes and the complete cases analyzes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo.
- •Guardians who have signed the informed consent confirming their participation and their child in research.
排除标准
- •Children showing visible dental plaque and gingivitis in baseline.
- •Children showing more than 08 active and/or inactive caries cavitated surfaces, and who show fistula and/or dental abscess.
- •Special patients.
- •Children who received professional application of fluoride in the 6 months prior to the survey.
研究组 & 干预措施
Group 1 - Recall Interval of 12 months
Oral clinical conditions:
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
干预措施: Oral clinical conditions (Procedure)
Group 2 - Recall Interval of 18 months
Oral clinical conditions:
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
干预措施: Oral clinical conditions (Procedure)
结局指标
主要结局
Dental caries incidence - Change
时间窗: Baseline, 12 months and 18 months
Dental caries will be assessed using the ICDAS criteria (Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, et al. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol 2007; 35: 170-8).
次要结局
- Level of anxiety - Change(Baseline, 12 months and 18 months)
- Oral health related quality of life - Change(Baseline, 12 months and 18 months)
- Time(Baseline, 12 months and 18 months)
- Costs(Baseline, 12 months and 18 months)
研究者
Gabriela Oliveira Berti
PhD student
University of Sao Paulo