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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03478748
Other study ID # DFCO1505/0005P
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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