Back to resultsThe Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Dental health education
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries in Children focused on measuring Dental caries, Oral health literacy
Eligibility Criteria
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
Sites / Locations
- Batu Pahat Dental Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
one-to-one dental health education
anticipatory guidance technique
Arm Description
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.
Anticipatory guidance technique were applied where appropriate dental health education (according to the children's milestones) were provided to mothers and their children.
Outcomes
Primary Outcome Measures
Incidence of dental caries
Change from baseline dental caries prevalence at 3 years using visual and tactile examination
Secondary Outcome Measures
Mothers' oral health literacy
Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03478748
Brief Title
The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
Official Title
The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2015 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Dental caries, Oral health literacy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Both investigators and participants knew about the intervention and who were involved.
Allocation
Non-Randomized
Enrollment
478 (Actual)
8. Arms, Groups, and Interventions
Arm Title
one-to-one dental health education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
anticipatory guidance technique
Arm Type
Experimental
Arm Description
Anticipatory guidance technique were applied where appropriate dental health education (according to the children's milestones) were provided to mothers and their children.
Intervention Type
Other
Intervention Name(s)
Dental health education
Other Intervention Name(s)
Anticipatory guidance
Intervention Description
Anticipatory guidance given to mothers to promote their children's oral health.
Primary Outcome Measure Information:
Title
Incidence of dental caries
Description
Change from baseline dental caries prevalence at 3 years using visual and tactile examination
Time Frame
Baseline and 3 years
Secondary Outcome Measure Information:
Title
Mothers' oral health literacy
Description
Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments
Time Frame
Baseline and 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norintan Ab Murat, PhD
Organizational Affiliation
University of Malaya
Official's Role
Study Chair
Facility Information:
Facility Name
Batu Pahat Dental Clinic
City
Batu Pahat
State/Province
Johor
ZIP/Postal Code
83100
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30053849
Citation
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.
Results Reference
derived
Learn more about this trial
The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
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