NCT03478748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

February 26, 2018

Last Update Submit

March 23, 2018

Conditions

Keywords

Dental cariesOral health literacy

Outcome Measures

Primary Outcomes (1)

  • Incidence of dental caries

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

    Baseline and 3 years

Secondary Outcomes (1)

  • Mothers' oral health literacy

    Baseline and 3 years

Study Arms (2)

one-to-one dental health education

ACTIVE COMPARATOR

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 technique

EXPERIMENTAL

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

Interventions

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

Also known as: Anticipatory guidance
anticipatory guidance techniqueone-to-one dental health education

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Medically compromised children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batu Pahat Dental Clinic

Batu Pahat, Johor, 83100, Malaysia

Location

Related Publications (1)

  • Ismail A, Razak IA, Ab-Murat N. The impact of anticipatory guidance on early childhood caries: a quasi-experimental study. BMC Oral Health. 2018 Jul 27;18(1):126. doi: 10.1186/s12903-018-0589-0.

MeSH Terms

Conditions

Dental Caries

Interventions

Health Education, Dental

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health DentistryEnvironment and Public Health

Study Officials

  • Norintan Ab Murat, PhD

    University of Malaya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Both investigators and participants knew about the intervention and who were involved.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The model is an oral health education package that covers the following aspects: (i) cognitive component (for example, the provision of basic oral health knowledge using an anticipatory guidance technique); (ii) psychomotor component (for example, the demonstration of basic oral health skills such as toothbrushing skills with a hands-on practical); and (iii) attitude component (activities that help to improve the children's attitude towards oral health). Children (along with their older siblings and mothers) in the study group were required to make six-monthly visits to the dental clinic in the three-year study period. Those in the control group received the conventional Ministry of Health programme.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 27, 2018

Study Start

January 2, 2015

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations