Comparative evaluation of effectiveness of non- fluoridated grape seed derived proanthocyanidin varnish and Fluoride varnish in remineralization of enamel caries of permanent teeth in children – A Randomized Controlled Trial
概览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Chettinad Dental College and Research Institute
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in ICDAS II scores from baseline to 9 months, comparing the effectiveness of fluoride varnish and PAC varnish application every 3 months.
概览
简要总结
This is a double-blinded, split-mouth randomized clinical trial, consisting of 56 children aged 7-10 years with early enamel caries (ICDAS II scores 1, 2, and 3) in permanent 1st molars of both quadrants . Fluoride varnish (control) will be applied to one quadrant, and PAC gel (test) to the other every 3 months. The ICDAS II scores and Commission Internationale de l’Eclairage (CIE) Lab color scores using digital photographs will be determined at baseline, 3,6, 9 and 12 months and will be subjected to statistical analysis using repeated measures ANOVA to evaluate the remineralization potential of the test and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Helathy Children aged 7-10 years.
- •Presence of early enamel caries (ICDAS II scores 1, 2, and 3) in occlusal surfaces of permanent molars on left and right quadrants.
- •Parental/guardian consent to participate in the study.
排除标准
- •Children with systemic illnesses or children with special healhcare needs
- •Allergies to any of the study materials.
- •Tooth surfaces with proximal restorations;
- •Previous caries treatment on the selected teeth.
- •Use of fluoride supplements or professional fluoride treatments within the past six months.
结局指标
主要结局
Change in ICDAS II scores from baseline to 9 months, comparing the effectiveness of fluoride varnish and PAC varnish application every 3 months.
时间窗: At 4 points | Baseline | 3 months | 6 months | 9 months
次要结局
- Change in (CIE) Lab color scores of digital photographs from baseline to 9 months.(At 4 points)
研究者
Dr Rajeshwari B
Chettinad Dental College and Research Institute