Comparative evaluation of manual and ionic tooth brushing on oral health and microbial status of individuals with intellectual disabilities.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To find out the efficacy of ionic toothbrushes over manual toothbrushes on gingival inflammation based on Gingival Index
研究概览
简要总结
Comparative evaluation of manual and ionic tooth brushing on oral health and microbial status of individuals with intellectual disabilities.
1. To find out the efficacy of ionic toothbrushes over manual toothbrushes on gingival inflammation based on Gingival Index
2. To find out the efficacy of ionic toothbrushes over manual toothbrushes on plaques scores based on Plaque Index
3. To find out the efficacy of ionic toothbrushes over manual toothbrushes on reduction of oral microbiota .
Study proposes to assess the effectiveness of ionic based tooth brushes in maintaining oral hygiene; reducing gingivitis. A previous study showed that proportion of subjects showing important difference of 44% clinically improvement on power brushing as compared to normal brushing is acceptable.
Qualitative in depth interviews will be taken of caregivers to explore the problems and barriers encountered with routine oral hygiene measures. One-to-one interviews will be used to get the personal, medical and demographic data of the participants. Compliance and comments about the brushes will be determined by a pre validated questionnaire based survey. The care giver survey will consist of nine-point Likert-type items to allow for ratings of comfort level, acceptability and usefulness of tooth brush. Participants will be asked to provide open-ended feedback at the end of both the brusher and brushee surveys. Consent for participating in the study will taken from all volunteers. Instructions were given to use only the given brushes twice daily for 3 minutes by the assigned tooth brushing technique. Demonstration of tooth brushing technique will be given to all the participants and their caregivers by live demonstration and educational videos will be circulated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of both the genders with at least 20 erupted teeth.
- •Age group 7-30 years.
- •3.Subjects with mild to moderate degree of intellectual disability.
排除标准
- •1.Subjects with systemic diseases.
- •2.Subjects who have received any antibiotic therapy in the last 1 months or subjects taking drugs that could affect state of gingival tissues including corticosteroids and non-steroidal anti-inflammatory drugs.
- •Subjects with true periodontal pockets.
结局指标
主要结局
1.To find out the efficacy of ionic toothbrushes over manual toothbrushes on gingival inflammation based on Gingival Index
时间窗: From Baseline to end of treatment at the day 07,21,45,90
2.To find out the efficacy of ionic toothbrushes over manual toothbrushes on plaques scores based on Plaque Index
时间窗: From Baseline to end of treatment at the day 07,21,45,90
3.To find out the efficacy of ionic toothbrushes over manual toothbrushes on reduction of oral microbiota .
时间窗: From Baseline to end of treatment at the day 07,21,45,90
次要结局
- 1. Qualitative in depth interviews will be taken of caregivers to explore the problems and barriers encountered with routine oral hygiene measures.(2. Compliance and comments about the brushes will be determined by a pre validated questionnaire based survey. The care giver survey will consist of nine-point Likert-type items to allow for ratings of comfort level, acceptability and usefulness of tooth brush.)
研究者
Dr Rupali Kalsi
Government Institute of Medical Sciences (GIMS)