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Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries

Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558955
Enrollment
600
Registered
2024-08-19
Start date
2024-06-15
Completion date
2028-09-01
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Dental Caries in Children, Diet Habit

Keywords

Anticipatory Guidance, Peer Support, Oral Health, Technology, Dental Caries

Brief summary

Early Childhood Caries (ECC) is a significant clinical and public health challenge that the world and the Singapore population are facing. This study seeks to test the effectiveness of technology-enabled anticipatory guidance and peer support in empowering parents to establish proper childcare practices and prevent ECC.

Detailed description

The study design is a two-arm, parallel group, assessor-blinded, randomised controlled trial. The hypothesis is that technology-enabled anticipatory guidance and peer support is more effective than conventional oral health education in enhancing parental efficacy, establishing proper childcare practices (dietary, feeding and toothbrushing), and preventing ECC. Up to 600 mother-child dyads will be recruited and randomly assigned to receive conventional oral health education (control), and technology-enabled anticipatory guidance and peer support (intervention), respectively. For the intervention arm, anticipatory guidance and peer support will be delivered through 4 unique online sessions for mothers, when each child turns 3, 6, 12, and 18 months, to match the developmental milestones and parental needs for childcare support. Outcomes will be assessed through a questionnaire and food diary (at 12, 24 and 36 months of child's age) and a dental examination for the child (at 24 and 36 months of age). The effectiveness of the intervention will be evaluated using psychological outcomes (parental efficacy), behavioral outcomes (dietary, feeding and oral hygiene practices), and clinical outcomes (oral hygiene and ECC), and quality of life outcomes. Process evaluation and cost-effectiveness analysis will be included. Data will be analyzed on an intention-to-treat basis, including with the last observation carried forward method. Descriptive statistics on socio-demographic backgrounds, parental efficacy, childcare practices, child's oral health status, and oral health related quality of life will be reported. Chi-square test and two-sample t-test, or their non-parametric equivalents, will be used as appropriate to compare proportions and means between the control and intervention groups. Effect sizes and number needed to be treated will be presented to provide an estimate of the number of parents needed to be intervened in order to avoid one child with new dental caries. Multivariable analyses will be performed to evaluate the effectiveness of the intervention.

Interventions

BEHAVIORALTechnology-enabled anticipatory guidance and peer support

The intervention includes 4 online sessions led by an oral health therapist (OHT) or dentist, as well as push notifications and information delivered to participants via a mobile/web app.

Participants on this arm will receive conventional child oral health education materials at 4 time points.

Sponsors

National University of Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Mother is currently expecting or has an infant below 3 months of age * Biological mother of the child * Mother with internet access and a mobile device * Mother can communicate in English * Mother aged 21 years and above

Exclusion criteria

* Child with disqualifying medical condition (e.g., tube feeding, severe neuromuscular disability) that would limit oral dietary intake, at-home oral hygiene practices, or receipt of dental examinations * Child with serious congenital syndrome that is expected to adversely affect the development of primary teeth * Family plans to emigrate within 3 years

Design outcomes

Primary

MeasureTime frameDescription
Incidence of early childhood caries24 and 36 months of age for childrenNumber of new surfaces with coronal caries

Secondary

MeasureTime frameDescription
Dietary and feeding practices (favourable/unfavourable)12, 24 and 36 months of age for childrenSelf-reported frequency of snack, sweet/dessert and sugary drink intake
Dental Utilisation12, 24 and 36 months of age for childrenSelf-reported frequency of dental visits
Dental Costs12, 24 and 36 months of age for childrenSum of direct costs from dental treatment and indirect costs due to time taken off work by parents to attend dental visits, and loss of productivity. Costs will be captured in Singapore dollars (SGD).
Toothbrushing behaviours12, 24 and 36 months of age for childrenUsing a questionnaire, toothbrushing behaviours will be categorised as: 1. Favourable (frequency of brushing \>=2times/day) 2. Unfavourable (frequency of brushing \<2times/day)
Plaque score24 and 36 months of age for childrenPlaque score based on the index recommended by Ramjford and modified for primary dentition. The plaque score is coded as following: 2 = visible plaque without use of probe, 1 = no visible plaque but a probe skimmed over the tooth surface reveals plaque, 0 = no plaque. Scoring is done at three sites (interproximal, buccal and palatal/lingual) on the index teeth (#54, #61, #64, #74, #81, #84).
Breastfeeding rate12 and 24 months of age for childrenDuration of breastfeeding (in months)
Parental efficacy in managing oral health of child12, 24 and 36 months of age for childrenMeasured using the self-efficacy scale for maternal oral care (SESMO). Response options (Yes and No). A score of 1 is given for an answer with higher self-efficacy and 0 for lower self-efficacy. Minimum score is 0 and maximum score is 16 for the 16 questions. Higher scores indicate better outcomes.

Countries

Singapore

Contacts

Primary ContactXiaoli Gao, PhD
dengx@nus.edu.sg(65) 6772 4990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026