Efficacy of Resin Infiltration of Proximal Caries Tested With DIAGNOcam and Bitewing Radiography:Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- pairwise bitewing radiograph and DIAGNOcam image
研究概览
简要总结
The aim of the present study was to assess the clinical efficacy of resin infiltration of interproximal caries lesions using a novel measure method-----DIAGNOcam. This study is conducted on adults (15-40y）with the aim of comparing the therapeutic effects of infiltrating caries lesions and fluoride remineralization treatment after 1, 2, and 3 yrs. The outcome (lesion progression) is evaluated by DIAGNOcam and radiographic techniques.And we would compare the sensitivity of monitoring progression of caries between DIAGNOcam and bitewing radiography.
详细描述
On the baseline,At a screening visit, eligibility of interested participants is checked with DIAGNOcam by a researcher(WF),in addition,a pair of standardized conventional bitewing radiographs is taken using a film holder Kwik-Bite by a very experienced dental assistant .
two reviewers(SC、XYJ) who are trained the scoring systems score the DIAGNOcam and bitewing image independently,disagreements are solved by consensus and a final DIAGNOcam and bitewing score are given.Participants who have two E2 lesions are picked to join the first set up.
A.DIAGNOcam image scoring system:
E1:Dark shadow confined to the out half of the enamel E2:Dark shadow confined to the inner half of the enamel D1:Dark shadow reach dentin ,dentin caries penetrating the enamel-dentin junction linerly D2:Deep dentin are involved
B .bitewing radiograph scoring system:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals who want to participate in the study ,the presence of 2 or more non-cavitated interproximal caries lesions with dark shadow involved in the enamel on the DIAGNOcam image -
排除标准
- •patient who diagnosed with dentinogenesis imperfecta
研究组 & 干预措施
resin infiltration
resin infiltrant (Icon product, DMG, Hamburg,Germany)
干预措施: resin infiltration (Other)
remineralization
干预措施: remineralization (Other)
remineralization
干预措施: sham (Other)
结局指标
主要结局
pairwise bitewing radiograph and DIAGNOcam image
时间窗: after three years
comparing the outcome of bitewing radiograph and DIAGNOcam image of pre- and post- operation
次要结局
- compare the cost-effectiveness between resin infiltration and remineralization(after three year years)
研究者
Fei Wang
graduate student
Wuhan University