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Clinical Trials/NCT04885348
NCT04885348CompletedNot Applicable

The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children - a Randomised Controlled Trial

Ministry of Education, Malaysia0 sites329 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
329
Primary Endpoint
Number of children developing new caries in deciduous molars.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
5 Years to 6 Years (Child)
Sex
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

  • Not provided

Arms & Interventions

Dental Home Education Leaflets

Active Comparator

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

Intervention: Control Group (Dental Home Education Leaflets) (Behavioral)

Dental Home Visits and Dental Home Education Leaflets

Experimental

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.

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

Dental Home Visits and Dental Home Education Leaflets

Experimental

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.

Intervention: Control Group (Dental Home Education Leaflets) (Behavioral)

Outcomes

Primary Outcomes

Number of children developing new caries in deciduous molars.

Time Frame: 2 years

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

Number of in deciduous molars developing new caries.

Time Frame: 2 years

New caries detected in deciduous molars at the cavitation stage.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ministry of Education, Malaysia
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Professor Allan Pau

Principal investigator

Ministry of Education, Malaysia

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