NCT06558955

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jun 2024Sep 2028

Study Start

First participant enrolled

June 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

3.5 years

First QC Date

July 15, 2024

Last Update Submit

August 15, 2024

Conditions

Keywords

Anticipatory GuidancePeer SupportOral HealthTechnologyDental Caries

Outcome Measures

Primary Outcomes (1)

  • Incidence of early childhood caries

    Number of new surfaces with coronal caries

    24 and 36 months of age for children

Secondary Outcomes (7)

  • Toothbrushing behaviours

    12, 24 and 36 months of age for children

  • Dietary and feeding practices (favourable/unfavourable)

    12, 24 and 36 months of age for children

  • Dental Utilisation

    12, 24 and 36 months of age for children

  • Dental Costs

    12, 24 and 36 months of age for children

  • Parental efficacy in managing oral health of child

    12, 24 and 36 months of age for children

  • +2 more secondary outcomes

Study Arms (2)

Technology-enabled anticipatory guidance and peer support

EXPERIMENTAL

Participants (mothers) will join online parent empowerment sessions for about 4 times (around 3, 6, 12, and 18 months of child's age, around 45 - 60 minutes each), and receive additional information and push notifications via a mobile phone app.

Behavioral: Technology-enabled anticipatory guidance and peer support

Conventional oral health education

ACTIVE COMPARATOR

Participants (mothers) will receive child oral health information for about 4 times (around 3, 6, 12, and 18 months of child's age).

Behavioral: Conventional health education

Interventions

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.

Technology-enabled anticipatory guidance and peer support

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

Conventional oral health education

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Related Publications (1)

  • Gao X, Tan SHX, Hong CHL, Chong MFF, Wong ML, Ng YPM, Koh GCH, Foong PS, Pramanick A, Eu OC, Gallagher JE, Amin Z. Technology-enabled anticipatory guidance and peer support in empowering parents to prevent early childhood caries: a randomized controlled trial. BMC Oral Health. 2024 Dec 4;24(1):1470. doi: 10.1186/s12903-024-05204-7.

MeSH Terms

Conditions

Dental CariesFeeding Behavior

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesBehavior, AnimalBehavior

Study Officials

  • Xiaoli Gao, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Gao, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 15, 2024

First Posted

August 19, 2024

Study Start

June 15, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations