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

Not Applicable

Completed

• Conditions: Dental Caries in Children

• Registration Number: NCT03478748
• Lead Sponsor: University of Malaya

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-01-02
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Study First Submitted: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-23
• Last Update Submitted: 2018-03-23
• Study First Posted: 2018-03-27
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 478

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of dental caries	Baseline and 3 years	Change from baseline dental caries prevalence at 3 years using visual and tactile examination

Secondary Outcome Measures

Name	Time	Method
Mothers' oral health literacy	Baseline and 3 years	Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments

Trial Locations

Locations (1)

Batu Pahat Dental Clinic; 🇲🇾 Batu Pahat, Johor, Malaysia