Comparative evaluation of the unripe Aegle marmelos ,Mangifera indica Leaves and their combination, with Kidodent as a mouthwash in reduction of salivary S. mutans count in children –A randomisied controlled clinical study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the reduction of S.mutans count in children following the administration of herbal mouthwashes
研究概览
简要总结
The aim of this In-vivo study is Comparative evaluation of antimicrobial efficacy of herbal extracts of unripe Aegle marmelos fruit ,Mangifera indica leaves and their combination with kidodent against caries causing Streptococcus *mutans.*The study will be undertaken in the residential schools of Raichur district .A total of 60 participants divided into 4 groups with 15 in each group will be selected. Herbal mouthwashes will be prepared from ethanolic extracts of unripe Aegle marmelos fruit ,Mangifera indica leaves . Before initiating the study oral prophylaxis will be performed and saliva samples will be collected from the selected participants to evaluate the base line S mutans count and salivary pH. The prepared herbal mouthwashes will be given to the selected groups daily in the morning for 28 days. S mutans and salivary pH count will be evaluated on 7th, 14th and 28th day.
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
- 9.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of age between 9-12 years with good general health, devoid of any infectious diseases and willing to co operate for the study will be selected.
排除标准
- •Children who cannot expectorate completely
- •Any intraoral pathology
- •Using any oral hygiene aids,
- •Children on antibiotics in the month before and during the research period.
- •With any sort of intraoral prosthesis or undergoing orthodontic treatment
- •The one not available for the follow up phase.
结局指标
主要结局
To evaluate the reduction of S.mutans count in children following the administration of herbal mouthwashes
时间窗: Evaluate the S.mutans count on 1st, 7th,14th and 28th day of the study
次要结局
- To evaluate patient acceptance and adverse effects of herbal mouthwashes on oral tissues(28 days)
研究者
Revati
AMES Dental College and Hospital