The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children
1 other identifier
interventional
329
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedMay 26, 2021
May 1, 2021
2.3 years
May 1, 2021
May 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of children developing new caries in deciduous molars.
The number of children developing caries in deciduous molars over the two years follow up.
2 years
Number of in deciduous molars developing new caries.
New caries detected in deciduous molars at the cavitation stage.
2 years
Study Arms (2)
Dental Home Visits and Dental Home Education Leaflets
EXPERIMENTALTwo trained dental home visitors made 6-monthly Dental Home Visits (DHVs) to families in the Intervention Group. Dental Home Education Leaflets (DHELs) and oral health messages were delivered through a personalized approach that avoids direct persuasion.
Dental Home Education Leaflets
ACTIVE COMPARATOROnly Dental Home Education Leaflets were provided every six months for 2 years.
Interventions
No drugs were given in the Intervention. The intervention group received Dental Home Visits consisted of 6 monthly home visits by oral health therapists/dental home visitors where they deliver dental care advice to the parents for durations of approximately 30 minutes until follow-up at two years. Dental Home Education Leaflets (DHELs) and oral health messages were delivered through a personalized approach that avoids direct persuasion. These messages included information on daily tooth brushing with fluoride toothpaste, controlling dietary sugar intake, and the need for regular dental check-ups. The families were also be provided with information about local dental services available in their vicinity and how to access these services.
Only Dental Home Education Leaflets were provided every six months for 2 years.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 17128231BACKGROUNDM E Drummond, M J Sculpher, G W Torrance GW, et al. Oxford University Press, 2005. ISBN 0-19-852945-7
BACKGROUNDMasood 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.
PMID: 23158416BACKGROUNDSeow 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.
PMID: 9671196BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 1, 2021
First Posted
May 13, 2021
Study Start
January 1, 2017
Primary Completion
May 1, 2019
Study Completion
June 1, 2019
Last Updated
May 26, 2021
Record last verified: 2021-05