Comparative evaluation of probiotic toothpaste and aloe vera tooth gel in reducing streptococcus mutans level in plaque around orthodontic brackets: A randomized controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cycle threshold value (Ct)
研究概览
简要总结
This is a randomized, double blinded, controlled study which aims to evaluate and compare the effects of Probiotic toothpaste and Aloe Vera tooth gel in the reduction of streptococcus mutans level in plaque around orthodontic brackets. A total of 60 randomly selected orthodontic patients will be enrolled in this study. They will be divided into 3 groups of 20 each. Group I is the control group using the regular fluoride toothpaste . Patients in group II will be asked to use Probiotic toothpaste and group III patients will be asked to use Aloe vera tooth gel. All the patients will be asked to brush their teeth twice daily in the morning and evening for a time period of 30 days.Samples will be collected at 2 times: before the study began and after 30 days. Plaque specimens will be collected from the labial surfaces immediately surrounding the orthodontic brackets of the maxillary lateral incisor using a 4-pass technique. The quantification of S.mutans will be evaluated using quantitative real time polymerase chain reaction.Cycle threshold value (Ct) is the primary outcome. Intragroup and intergroup analysis will be done based on the Ct value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •1.Orthodontic treatment with straight wire appliance.
- •Permanent dentition with full compliment of teeth excluding third molars.
- •No relevant medical history.
- •No anti-inflammatory or antibiotic medications taken in the month before and during the study.
- •No chewing gum or mouthwash usage in the week preceding and during the study.
- •Habit of brushing twice daily with fluoride toothpaste.
- •Age between 12 and 35 years.
- •8.Fixed orthodontic treatment started atleast 6 months before sample collection.
排除标准
- •Mixed dentition.
- •Previous history of orthodontic treatment.
- •Tooth with developmental anomalies and fluorosis.
- •Restoration involving labial surface of tooth.
- •Pregnancy, lactation and diabetics
- •Patients with habit of smoking.
- •Patient allergic to aloe vera.
- •Tendency for frequent vomiting.
- •Participants with unavoidable drug intake during the study period.
结局指标
主要结局
Cycle threshold value (Ct)
时间窗: 30 days
次要结局
- Cycle threshold value (Ct)(Ct value before intervention and after 30 days)