Radiographic Progression of Early Caries Lesions After Resin Infiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
研究概览
简要总结
The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.
详细描述
A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
- •Having at least two early caries lesions in approximal posterior tooth surfaces
- •Lesions visible on radiograph
排除标准
- •Current participation in another clinical study
- •Medically compromised subjects
- •Hyposalivation
- •Pregnancy
- •Allergic to methylmethacrylates
- •Allergic to latex
- •Symptomatic teeth
研究组 & 干预措施
Control
Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
干预措施: Sham treatment (Device)
Resin infiltration
Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
干预措施: Resin infiltration (Device)
结局指标
主要结局
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
时间窗: 3 Years
Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)
次要结局
- Number of Lesions With Progression as Measured by Depth Category (N=Lesions)(3 Years)
研究者
Mathilde Peters, DMD, PhD
Professor Emerita
University of Michigan