Influence of Nano-hydroxyapatite and Ozone on Approximal Initial Caries
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 主要终点
- Remineralizing effect
研究概览
简要总结
Objectives: to assess the efficiency of three methods of enamel remineralization on initial approximal caries: 1. a nano-hydroxyapatite gel, 2. gaseous ozone therapy 3. combination of a nano-hydroxyapatite gel and ozone.
Materials and Methods: Patients (n=92, age 20-30y) with initial approximal enamel lesions on premolar and molar teeth (n=546) randomly allocated to three groups subjected to a 6-months treatment: Group I: domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both remineralizing gel and ozone therapy. Caries lesions assessed on bitewing radiographs at baseline, after 1 year and after 2 years.
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
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •initial approximal enamel lesions on premolar and molar teeth
排除标准
- •distal surface of the last tooth in arch, overlapping teeth
- •fillings on approximal surfaces of teeth of interest
- •ongoing orthodontic therapy with braces or other appliances
研究组 & 干预措施
domestic nanohydroxyapatite gel ApaCare & Repair
6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
干预措施: ApaCare & Repair (Other)
in-office ozone therapy OzonyTron
6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
干预措施: ApaCare & Repair (Other)
both remineralizing gel and ozone therapy
6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
干预措施: ApaCare & Repair (Other)
结局指标
主要结局
Remineralizing effect
时间窗: baseline
Caries lesions were assessed on bitewing radiographs
次要结局
- Remineralizing effect - follow-up(after 1 year and after 2 years)
研究者
Katarzyna Grocholewicz
Prof. DDS, PhD
Pomeranian Medical University Szczecin