Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Caries progression rate
研究概览
简要总结
The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.
详细描述
The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after 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 (Participant)
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with one tooth surface with active caries lesions
- •two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
- •asigned informed consent.
排除标准
- •children who do not cooperate during dental appointments
- •primary molars supposed to exfoliate in less than two years
- •lesions showing obvious cavitation or clear sings of inactivity
研究组 & 干预措施
Control
This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.
干预措施: Control (Device)
Resin infiltration
This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.
干预措施: Resin infiltration (Device)
结局指标
主要结局
Caries progression rate
时间窗: 1 year
Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
次要结局
- Caries risk(Baseline, 6 months, 1 year, 2 years, 3 years)
- Caries progression rate(2 years, 3 years)
- Stress reaction during treatment(Immediate)