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

March 23, 2018 updated by: Norintan Ab Murat, University of Malaya
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

478

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Johor
      • Batu Pahat, Johor, Malaysia, 83100
        • Batu Pahat Dental Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: one-to-one dental health education
Conventional oral health education programme that mainly focuses at child level, which has been the normal practice at the Ministry of Health, were provided to the control participants.
Other: Dental health education
Anticipatory guidance given to mothers to promote their children's oral health.
Other Names:
  • Anticipatory guidance
Experimental: anticipatory guidance technique
Anticipatory guidance technique were applied where appropriate dental health education (according to the children's milestones) were provided to mothers and their children.
Other: Dental health education
Anticipatory guidance given to mothers to promote their children's oral health.
Other Names:
  • Anticipatory guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dental caries
Time Frame: Baseline and 3 years
Change from baseline dental caries prevalence at 3 years using visual and tactile examination
Baseline and 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Chair: Norintan Ab Murat, PhD, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2015

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFCO1505/0005P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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