CTRI/2019/01/016897尚未招募2/3 期
Comparison of efficacy of dentifrices containing mangifera indica extract and fluoride on salivary streptococcus mutans count and plaque accumulation among 12 – 15 years school children in Davangere city – A randomized controlled trial
未提供1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年1月17日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 1.To assess and compare the antiplaque and antibacterial efficacy of Mangifera indica extract dentifrice, commercially available Fluoridated dentifrice (Colgate total care) and a Placebo dentifrice on salivary Streptococcus mutans levels and plaque levels among 12 – 15 years old school children in Davanagere city
研究概览
简要总结
| This is a randomized, triple blinded, parallel group trial to evaluate the efficacy of dentifrices containing mangifera indica extract and fluoride on salivary streptococcus mutans count and plaque accumulation among 12 – 15 years school children in Davangere city. A Two stage random sampling method will be followed for recruitment of participans. Sample size calculation was done using G Power software by fixing the effect size at 0.4. 84 participants were equally divided into 3 groups containing test group , placebo group and control group. Baseline and post-test assessment will be done after 3 weeks, for streptococcus mutans count and Plaque score will be assessed by applying Turesky Gilmore Glickman modification of the Quigley Hein Plaque index. Comparison of salivary streptococcus mutans counts and plaque scores within group will be done by Students paired ‘t’ test and comparison of salivary streptococcus mutans counts and plaque score will be done at baseline and after 3 weeks for three dentifrices using one way ANOVA followed by post hoc Tukey’s test . |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects whose parents will give consent for their children to participate in study.
- •Subjects having at least one cavitated active carious lesion A cavitated active lesion – is a well-defined cavity with exposed dentin, yellowish or light brown in colour, which feels soft on gentle probing.
- •Having a streptococcus mutans count of equal to or more than 105 CFU per ml of saliva (microbiological selection criteria) 4.Subjects with a baseline mean plaque index score of at least 1.5 as determined by the use of the Turesky modification of the Quigley-Hein Plaque Index.
- •Subjects with presence of more than 20 scoreable teeth in the oral cavity.
排除标准
- •Subjects on medications and subjects with systemic diseases that affect their salivary flow rate.
- •History of hypersensitivity to any product used in the study
- •History of antibiotic therapy in the previous one month till the start of the study.
- •Subjects who will be unable to comply with the study appointment Schedules
- •Subjects using orthodontic appliances
- •Subjects using adjunctive oral hygiene aid like mouthwash.
结局指标
主要结局
1.To assess and compare the antiplaque and antibacterial efficacy of Mangifera indica extract dentifrice, commercially available Fluoridated dentifrice (Colgate total care) and a Placebo dentifrice on salivary Streptococcus mutans levels and plaque levels among 12 – 15 years old school children in Davanagere city
时间窗: 1.21 days after intervention
次要结局
未报告次要终点
研究者
研究点 (1)
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