Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- New root caries lesions and restorations
研究概览
简要总结
The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.
详细描述
This 36-month, double-blind, two-arm randomized controlled trial is aimed to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.
Participants will be divided in to two groups, The main question it aims to answer is: Is fluoride varnish with SBGC more effective than that without SBGC on prevention root caries in community-dwelling older adults? Participants will be divided into two groups, experimental group and controlled group after randomization. Subjects in the experimental group will receive fluoride varnish with SBGC quarterly, and subjects in the controlled group will receive fluoride varnish without SBGC quarterly.
It is hypothesized that community-dwelling older adults who receive quarterly fluoride varnish applications containing SBGC will develop fewer root caries.
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
- Double (Participant, Investigator)
盲法说明
The subjects and the clinical team including the dentist and the dental surgery assistant will all be blinded to the subjects' assignment of the intervention.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult > 60 years old
- •good collaborative relationships
排除标准
- •less than 8 natural teeth
- •have severe medical conditions
- •are in use of high fluoride toothpaste
研究组 & 干预措施
Fluoride varnish with SBGC
This group will receive applications of fluoride varnish (containing 5% NaF) with 7.5% SBGC every 3 months for 36 months.
干预措施: Fluoride varnish with SBGC (Combination Product)
Fluoride varnish without SBGC
This group will receive 5% NaF varnish with SBGC every 3 months for 36 months.
干预措施: Fluoride varnish (Drug)
结局指标
主要结局
New root caries lesions and restorations
时间窗: Baseline, 12, 24, 36 months
All exposed root surfaces will be examined for new caries lesions based on the ICDAS criteria. Restorations due to root caries will also be recorded after confirmation with the subjects.
次要结局
- Arrested root caries(Baseline, 12, 24, 36 months)
- Satisfaction of the use of varnish(12, 24, 36 months)