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

Study Overview
=================
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.

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

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Other: Dental health education


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: one-to-one dental health education<br>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<br>* Anticipatory guidance given to mothers to promote their children's oral health.<br>* Other names: Anticipatory guidance;|
| Experimental: anticipatory guidance technique<br>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<br>* Anticipatory guidance given to mothers to promote their children's oral health.<br>* Other names: Anticipatory guidance;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dental caries | 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 | Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments | Baseline and 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental caries, Oral health literacy