Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth: a Randomized Placebo-controlled Study.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Dental Caries
- 发起方
- University of Sao Paulo
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- progression of initial lesion caries
- 最后更新
- 10年前
概览
简要总结
This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.
详细描述
The sample will be comprised of 141 patients between 3 to 10 year-old and 504 proximal surfaces of 12-to-17-year-old adolescents, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.
研究者
Mariana Minatel Braga
Phd
University of Sao Paulo
入排标准
入选标准
- •Primary teeth: distal surface of the first molar, mesial surface of the second molar and distal surface of the second molar (when the first permanent molar is present) with initial caries lesion (ICDAS 1, 2 or 3).
- •Permanent teeth: distal surface of the first premolar, mesial surface of the second premolar, distal surface of the second premolar, mesial surface of the first molar, distal surface of the first molar and mesial surface of the second molar with initial caries lesion (ICDAS 1, 2 or 3).
排除标准
- •Mesial surface of the first primary molar/premolar by the smaller contact with the distal surface of the canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.
结局指标
主要结局
progression of initial lesion caries
时间窗: 12 and 24 months
次要结局
- approximal plaque reduction(1, 3, 6, 12, 18 and 24 months)