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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478748
• Other study ID #: DFCO1505/0005P
• Status: Completed
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 23, 2018
• Start date: January 2, 2015
• Est. completion date: December 15, 2017

Study information

• Verified date: March 2018
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Other:
• Dental health education
Anticipatory guidance given to mothers to promote their children's oral health.

Locations

Country	Name	City	State
Malaysia	Batu Pahat Dental Clinic	Batu Pahat	Johor

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dental caries	Change from baseline dental caries prevalence at 3 years using visual and tactile examination	Baseline and 3 years
Secondary	Mothers' oral health literacy	Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments	Baseline and 3 years