Radiographic Progression of Infiltrated Caries Lesions In-vivo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)
研究概览
简要总结
This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.
详细描述
A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 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 infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.
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
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14-35 year old subjects
- •decayed-missing-filled permanent teeth (DMFT) ≥ 3
- •having at least two early caries lesions in approximal posterior tooth surfaces
- •lesion 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
Preventative measures
Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
干预措施: Caries management (Behavioral)
Lesion infiltration
Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
干预措施: Caries management (Behavioral)
Lesion infiltration
Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
干预措施: Resin infiltration (Device)
结局指标
主要结局
Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)
时间窗: Baseline through 3 years
Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).
次要结局
- Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories(Baseline through 3 years)
- Lesion Survival After 3 Years(3 years)
研究者
Mathilde Peters, DMD, PhD
Professor
University of Michigan