A community-based pragmatic, controlled trial for prevention and reduction of oral diseases among children at the anganwadi centres located in peri-urban areas of Chandigarh and rural parts of Cuttack, Orissa.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,900
- 试验地点
- 2
- 主要终点
- Change in decayed missing filled surfaces (dmfs) score among children who were aged 1 to 3 years at the start of study
研究概览
简要总结
The present proposal is a pragmatic community-based, controlled, intervention trial proposed to be carried out in peri-urban areas of Chandigarh and rural areas of Cuttack, Orissa. Two geographically distant ICDS blocks would be selected at each of the two study centres viz. Chandigarh and Cuttack. The two selected blocks would be randomly allocated to intervention and control group using sealed envelopes. Anganwadi centres under each of the two selected blocks shall be enumerated and those anganwadi centres would be selected which are located closer to each other so that a cluster of anganwadi centres is formed within the block. Oral Health Care Package (OHCP) would be delivered to all the 0-6 year old children in the experimental group anganwadi centres whereas mothers and their children visiting the anganwadi centres under control group will only receive usual care available at the anganwadi centres. The primary analysis will be inter-group comparison of a cohort of children aged 1 to 3 years who will be recruited at the beginning of the study and shall be followed up for 3 years until the age of 4 to 6 years respectively for difference in dental caries levels, salivary S mutans levels and gingival disease status. Secondarily, a cross-sectional inter-group comparison of all available children aged 1 to 6 years present at the end of the study shall also be carried out. Similarly KAP regarding oral health among anganwadi workers and mothers shall be evaluated before intervention and at 6 months, 1 year, 2 year and 3year in cohort and cross-sectional manner. Up scaling of the project can be done to other anganwadi centres of the country if the present approach is found to be effective and practical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •(a)Children of the age 1 to 6 years.
- •(b)Child with at least one primary tooth present.
排除标准
- •(a) Involvement in other clinical trials or protocols related to oral health interventions (b) Allergy to the varnish’s component or povidone iodine (c) If no teeth or only stainless steel crowns are present.
结局指标
主要结局
Change in decayed missing filled surfaces (dmfs) score among children who were aged 1 to 3 years at the start of study
时间窗: three-year follow-up period from the initial assessment at the begining of study
次要结局
- Change in (i) S. Mutans levels, (ii) gingival disease status among children who will be aged 1 to 3 years at the start of study and change in KAP scores of their mothers(three-year follow-up period from the initial assessment at the begining of study)
- Change in dmfs score, S. mutans levels, GI score among children aged 1 to 3 years and KAP scores of their mothers(at 6 months, 1 year and 2 year follow-up period from the initial assessment at the begining of study)
- Raw dmfs scores, S. mutans levels, GI score among all available children aged 1 to 6 years and KAP scores of their mothers(at 6 months, 1 year, 2 year and 3 year follow-up period from the initial assessment at the begining of study)