Evaluation Of Efficacy Of Sr doped BAG Nanoparticle-Incorporated Orthodontic Primer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- to compare the changes in amount of enamel demineralization around orthodontic brackets.
研究概览
简要总结
A double blinded randomized controlled clinical trial with a split-mouth design investigating the efficacy of strontium-doped bioactive glass (Sr-BAG) nanoparticle-incorporated orthodontic primer in the management of white spot lesions in patients with fixed orthodontic therapy. The study will include 22 participants, each receiving the Sr-BAG and control primers on contralateral sides of the mouth (a split-mouth design), making it a total sample size of 44 (intervention group n=22, control group n=22). Outcome measures included comparison of the Sr-BAG primer and the control primer (Transbond) in terms of the incidence of white spot lesions (WSLs) or the degree of demineralization, assessed using a DIAGNOdent pen at three different time points during the clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who will be undergoing fixed orthodontic therapy, Patients with a full set of permanent maxillary anterior teeth, patients who were caries-free and with healthy periodontal tissue were included.
排除标准
- •patients with fluorosed teeth or restoration on facial surface of upper anterior teeth.
结局指标
主要结局
to compare the changes in amount of enamel demineralization around orthodontic brackets.
时间窗: immediately after bonding (T0), 1 month after bonding (T1), | 6 months after bonding (T2)
次要结局
未报告次要终点
研究者
Amritha Nehru
Saveetha Dental College and Hospital