The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention Group (Dental Home Visits + Dental Home Education Leaflets)
Control Group (Dental Home Education Leaflets)
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries in Children focused on measuring Dental Caries, Dental Health Home Visits, Young Children, Dental Decay
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dental Home Visits and Dental Home Education Leaflets
Dental Home Education Leaflets
Arm Description
Two 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.
Only Dental Home Education Leaflets were provided every six months for 2 years.
Outcomes
Primary Outcome Measures
Number of children developing new caries in deciduous molars.
The number of children developing caries in deciduous molars over the two years follow up.
Number of in deciduous molars developing new caries.
New caries detected in deciduous molars at the cavitation stage.
Secondary Outcome Measures
Full Information
NCT ID
NCT04885348
First Posted
May 1, 2021
Last Updated
May 24, 2021
Sponsor
Ministry of Education, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT04885348
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Education, Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Dental Caries, Dental Health Home Visits, Young Children, Dental Decay
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
329 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dental Home Visits and Dental Home Education Leaflets
Arm Type
Experimental
Arm Description
Two 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.
Arm Title
Dental Home Education Leaflets
Arm Type
Active Comparator
Arm Description
Only Dental Home Education Leaflets were provided every six months for 2 years.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group (Dental Home Visits + Dental Home Education Leaflets)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group (Dental Home Education Leaflets)
Intervention Description
Only Dental Home Education Leaflets were provided every six months for 2 years.
Primary Outcome Measure Information:
Title
Number of children developing new caries in deciduous molars.
Description
The number of children developing caries in deciduous molars over the two years follow up.
Time Frame
2 years
Title
Number of in deciduous molars developing new caries.
Description
New caries detected in deciduous molars at the cavitation stage.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
12. IPD Sharing Statement
Citations:
PubMed Identifier
17128231
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.
Results Reference
background
Citation
M E Drummond, M J Sculpher, G W Torrance GW, et al. Oxford University Press, 2005. ISBN 0-19-852945-7
Results Reference
background
PubMed Identifier
23158416
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.
Results Reference
background
PubMed Identifier
9671196
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.
Results Reference
background
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The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children
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