Clinical trial NCT04885348: The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children
Official title: The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Dental Caries
Dental Health Home Visits
Young Children
Dental Decay
Lead sponsor: Ministry of Education, Malaysia
Sponsor class: OTHER_GOV
First posted: 2021-05-13
Enrollment: 329
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Tooth decay affects 75% of Malaysian preschool children, most of which remain untreated. Untreated decay can cause pain, and impair nutritional status and physical growth. In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of early childhood caries. The realistic management of these children would have been treatment under general anaesthesia or sedation, at considerable cost to the state, and distress to the children and families. The amount of dental disease in young children who have been referred to the hospital children's dentistry service for severe caries is disturbing, particularly given the fact that each district has a dental clinic and that the water is very likely to be fluoridated. It is unlikely that there will ever be enough dental clinics and dental practitioners to manage the amount of disease. Clearly, existing health services need to be supplemented with a population-based approach to promote child oral health. The investigators, therefore, propose a community trial study to investigate the effectiveness of a dental health visiting service for caries control in young children. It is likely that such a home-based intervention is influenced by the family dynamics in which the child lives. The investigators further propose to assess the cost-effectiveness of dental home visits (DHVs). Health economic evaluation can be used to assess health services to ensure there is cost-efficient resource allocation. Economic evaluation is defined as the comparative analysis of alternative courses of action in terms of both their costs and consequences. A health intervention is considered cost-effective when it produces acceptable costs and health benefits. Economic data are now recognized as important due to the fact that dental disease is very common and expensive for the health care system.

This study was conducted in collaboration with the National Oral Health of Pre-school Survey (NOHPS), in which a sub-sample will be followed up for two years. The NOHPS is a national survey of the oral health of 5-year-olds that takes place every 10 years.

This is a randomized controlled trial to assess the cost-effectiveness of home-based DHVs with families of children at high risk of caries in caries prevention compared to children receiving oral health information in the form of an education leaflet (ELs) alone. A collaborative project with the Oral Health Division (OHD) at the Ministry of Health is proposed. The OHD will provide access to a sub-sample from the National Oral Health Preschool Survey (NOHPS), with clinical dental health data.


Eligibility criteria: Inclusion Criteria:

* All the children age of 5 or 6-year-old with parents' consents to participate from these kindergartens will be included as the subjects of this study

Exclusion Criteria:

-

Primary outcomes:
measure: Number of children developing new caries in deciduous molars.
timeFrame: 2 years
measure: Number of in deciduous molars developing new caries.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sheiham A. Dental caries affects body weight, growth and quality of life in pre-school children. Br Dent J. 2006 Nov 25;201(10):625-6. doi: 10.1038/sj.bdj.4814259.
citation: M E Drummond, M J Sculpher, G W Torrance GW, et al. Oxford University Press, 2005. ISBN 0-19-852945-7
citation: Masood M, Yusof N, Hassan MI, Jaafar N. Assessment of dental caries predictors in 6-year-old school children - results from 5-year retrospective cohort study. BMC Public Health. 2012 Nov 16;12:989. doi: 10.1186/1471-2458-12-989.
citation: Seow WK. Biological mechanisms of early childhood caries. Community Dent Oral Epidemiol. 1998;26(1 Suppl):8-27. doi: 10.1111/j.1600-0528.1998.tb02090.x.