Evaluation of Enamel Remineralization Using a Novel Remineralizing Solution in patients undergoing Clear Aligner Therapy - A Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Enamel remineralization potential
研究概览
简要总结
Comparative Evaluation of Enamel Remineralization Using Aligner Trays with Novel Remineralizing Solutions Versus Alilgner Trays Without Remineralizing Agents- A Randomized Controlled Trial
Aim: The aim of this study is to evaluate and compare the enamel remineralization potential of aligner trays used in conjunction with a novel remineralizing solution versus those used without any remineralizing agent.
Objectives:
- To formulate a novel remineralizing solution containing Bioactive glass
- To assess cytotoxicity and antibacterial activity of the novel solution.
- To assess the remineralizing potential of the novel solution.
- To assess the effect of physical and chemical properties of aligner material on exposure to novel remineralizing solution
- To compare and evaluate the difference in the enamel remineralizing potential of the aligner trays used with a novel enamel remineralizing solution with those used without any remineralizing agent.
Sample Size: 20
Methodology
The methodology involves synthesizing a Bioglass based novel remineralizing solution. The sample size, determined using G*Power version 3.0.1 with a power of 0.8, consists of 20 patients undergoing clear aligner therapy. The study adopts a randomized controlled trial design with an intervention group exposed to the remineralizing solution along with normal oral hygiene procedures and the control group with just the normal oral hygiene procedures. Patients will be informed about the application protocol for the solution and a fixed routine oral hygiene procedure will be followed in both groups. After 3 months, the teeth from both groups will be evaluated for enamel remineralization. Additional assessment will include the color stability of the aligner trays. Informed consent will be obtained from all participants for the use of their case records in research and publication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 40.00 Year(s)（—）
入选标准
- •The patients age range between the age from 14 to 40 years old Gender can be males or females Good oral hygiene with a plaque index score 0 or 1 good general health patient compliance Active noncavitated carious white spot lesions Undergoing clear aligner therapy treatment No systemic diseases or concomitant medication affects salivary fow in order not to negatively affect the remineralizing process.
排除标准
- •Patients undergoing conventional orthodontic treatment Age outside 14 to 40 years Systemic diseases or medication Smoking or tobacco use Pregnancy and lacation.
结局指标
主要结局
Enamel remineralization potential
时间窗: 3 months
次要结局
- Colour stability(15 days of aligner use)
研究者
Siddhant Umesh Thorat
Saveetha Dental College