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NCT Number: NCT03478748

The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study

This study aimed to compare the impact of anticipatory guidance on the caries incidence of 2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers' oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.

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Key information

Conditions

Dental Caries in Children Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Batu Pahat Dental Clinic

Batu Pahat, Johor, 83100, Malaysia

About this study

This quasi-experimental study was conducted at two government dental clinics in Batu Pahat District, Malaysia. The samples comprised of 478 mother-child-sibling trios (233 families in the intervention group, and 245 families in the control group). An oral health package named the Family Dental Wellness Programme (FDWP) was designed to provide anticipatory guidance to the intervention group at six-month intervals over three years. The control group received the standard MOH oral health education activities. The impact of FDWP on net caries increment, caries prevented fraction, and mother's oral health literacy was assessed after three years of intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between the age of 2-3 years old
  • Older sibling aged 4 to 6 years categorized as having high caries risk based on a Caries Risk Assessment tool adapted from the American Association of Paediatric Dentistry
  • Mothers who were willing to participate in the study

Exclusion criteria

  • Medically compromised children

Treatment and study plan

Dental health education

Other

Anticipatory guidance given to mothers to promote their children's oral health.

Other names: Anticipatory guidance

Primary outcomes

  1. Incidence of dental caries

    Time frame: Baseline and 3 years

    Change from baseline dental caries prevalence at 3 years using visual and tactile examination

Secondary outcomes

  1. Mothers' oral health literacy

    Time frame: Baseline and 3 years

    Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 27, 2018
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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