The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children

Sponsor
Ministry of Education, Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT04885348
Collaborator
(none)
329
2
28.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention Group (Dental Home Visits + Dental Home Education Leaflets)
  • Behavioral: Control Group (Dental Home Education Leaflets)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
329 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children - a Randomised Controlled Trial
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dental Home Visits and Dental Home Education Leaflets

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.

Behavioral: Intervention Group (Dental Home Visits + Dental Home Education Leaflets)
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.

Behavioral: Control Group (Dental Home Education Leaflets)
Only Dental Home Education Leaflets were provided every six months for 2 years.

Active Comparator: Dental Home Education Leaflets

Only Dental Home Education Leaflets were provided every six months for 2 years.

Behavioral: Control Group (Dental Home Education Leaflets)
Only Dental Home Education Leaflets were provided every six months for 2 years.

Outcome Measures

Primary Outcome Measures

  1. Number of children developing new caries in deciduous molars. [2 years]

    The number of children developing caries in deciduous molars over the two years follow up.

  2. Number of in deciduous molars developing new caries. [2 years]

    New caries detected in deciduous molars at the cavitation stage.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ministry of Education, Malaysia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Professor Allan Pau, Principal investigator, Ministry of Education, Malaysia
ClinicalTrials.gov Identifier:
NCT04885348
Other Study ID Numbers:
  • IMU R 157/2014 (FRGS)
First Posted:
May 13, 2021
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Professor Allan Pau, Principal investigator, Ministry of Education, Malaysia
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2021