Effect of probiotic toothpaste on Streptococcus Mutans and Lactobacillus in saliva-A randomized control trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Levels of streptococcus mutans in saliva.
研究概览
简要总结
This study will check the effect of probiotic toothpaste on levels of Streptococcus mutans and Lactobacillus in saliva.The study will be conducted at Swami Devi Dyal Hospital And Dental College, and the participants for the study will be choosen from the hostel of dental college randomly. A total of 60 participants will be choosen who met the inclusion criteria. The choosen participants will be randomly divided into two groups of 30 each ,one group will be advised to brush with probiotic toothpaste and the other group with regular toothpaste for 30 days. It will be a double blinded randomized control trial, the participants will be provided with toothpaste in a separate container so that they will not be able to know which toothpaste they are using. The investigator herself will not be aware which participant is using which toothpaste and also saliva samples will be collected with the help of other pg students. Saliva samples will be collected at the baseline and microbiological analysis will be done in the Department of Microbiology of Swami Devi Dyal Hospital And Dental college itself. The participants will be called after on month for again saliva collection. Then the levels of Streptococcus mutans and Lactobacillus will be compared at baseline and after one month.
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 Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 18 to 25 years.
- •2.Participants with all fully erupted teeth.
- •3.Participants with inactive caries.
- •4.No underlying systemic condition.
- •5.Habit of brushing twice daily.
排除标准
- •1.Enrolled in any other clinical trial 30 days prior to randomization.
- •2.With major dental conditions such as periodontal disease, dental caries and/or xerostomia or systemic diseases which could directly or indirectly affect plaque formation.
- •3.Using any antimicrobial mouth rinses, probiotics (unrelated to the study) antibiotics or anti-inflammatories medications within one month prior to and during the study.
- •4.With allergies to any ingredient present in the lorodent probiotic complex.
- •5.Experiencing any nausea, fever, vomiting, bloody diarrhea or severe abdominal pain within the 30 days prior to commencing the study.
- •Those who were immunocompromised and/or had a major underlying medical condition or ENT problem.
- •7.Had recent (within the past 45 days) or planned (within the past 90 days) surgery of any kind.
- •8.With a history of smoking or alcohol consumption.
- •9.Pregnant and lactating females.
- •Who were unable to make informed consent.
结局指标
主要结局
1.Levels of streptococcus mutans in saliva.
时间窗: 1.Levels of streptococcus mutans and lactobacillus in saliva at baseline | 2.Levels of streptoccus mutans and lactobacillus in saliva after one month
2.Levels of lactobacillus in saliva.
时间窗: 1.Levels of streptococcus mutans and lactobacillus in saliva at baseline | 2.Levels of streptoccus mutans and lactobacillus in saliva after one month
次要结局
- 1.Change in levels of Streptococcus mutans and Lactobacillus in saliva after one month of probiotic toothpaste use.(1.Baseline (Day 0):)
研究者
Dr Twinkle Sharma
Swami Devi Dyal Hospital and Dental College