Clinical trial NCT03478748: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Dental caries
Oral health literacy
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 478
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of dental caries
timeFrame: Baseline and 3 years
Secondary outcomes:
measure: Mothers' oral health literacy
timeFrame: Baseline and 3 years
Other outcomes:
Locations:
city: Batu Pahat
country: Malaysia
facility: Batu Pahat Dental Clinic
state: Johor
Study officials:
affiliation: University of Malaya
name: Norintan Ab Murat, PhD
role: STUDY_CHAIR
References:
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.