Effect of a Behavioural Change Communication Intervention on the Oral Health Status of Young Children – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 660
- 试验地点
- 1
研究概览
简要总结
A randomised controlled trial will be adopted to assess the effect of Behaviour Change Communication Intervention on the oral health the oral health status and practices of pre-school children over 2.6 years. The population will consist of 660 children aged 2-4 years who will be consulting in the department of Paediatric and Preventive Dentistry of Amrita School of Dentistry, Amrita Institute of Medical Sciences. The study sample will be randomly allocated to any of the three trial groups including one control group. The study groups receive person-centered oral heath coaching with/without audio-visual media/standard care. Pertinent oral health information will be provided to all groups including the control group. Inter-group and intra-group statistical analysis will done appropriately using ANOVA, repeated measures ANOVA, Chi-square test and Kruskal Wallis test. Missing values will be handled using multiple imputation .Statistical significance will be set at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 4.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 2-4 years having no caries or not more than Type II ECC at the initiation of the study
- •Parents of children having a minimum education qualification up to graduation.
- •Parents willing to enroll their children for participation.
排除标准
- •1.Children having Type III ECC 2.Participants with known cognitive and psychological impairment.
- •3.Participants with any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of the participation in the trial, or may influence the result of the trial.
- •4.Participants who have participated in any similar research trial in the past 12 weeks.
研究者
Dr Arun Mamachan Xavier
Amrita School of Dentistry, Amrita Vishwa Vidyapeetham