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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
Ministry of Education, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

5 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 1, 2021
    Last Updated
    May 24, 2021
    Sponsor
    Ministry of Education, Malaysia
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    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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