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| ID | Type | Description | Link |
|---|---|---|---|
| PHRGOC23jul-0011 | Other Grant/Funding Number | National Medical Research Council, Singapore |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-enabled anticipatory guidance and peer support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early childhood caries | Number of new surfaces with coronal caries | 24 and 36 months of age for children |
| Measure | Description | Time Frame |
|---|---|---|
| Toothbrushing behaviours | Using a questionnaire, toothbrushing behaviours will be categorised as:
| 12, 24 and 36 months of age for children |
| Dietary and feeding practices (favourable/unfavourable) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Gao, PhD | Contact | (65) 6772 4990 | dengx@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoli Gao, PhD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39633367 | Derived | 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. |
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| Conventional health education | Behavioral | Participants on this arm will receive conventional child oral health education materials at 4 time points. |
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Self-reported frequency of snack, sweet/dessert and sugary drink intake |
| 12, 24 and 36 months of age for children |
| Dental Utilisation | Self-reported frequency of dental visits | 12, 24 and 36 months of age for children |
| Dental Costs | Sum 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). | 12, 24 and 36 months of age for children |
| Parental efficacy in managing oral health of child | Measured 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. | 12, 24 and 36 months of age for children |
| Plaque score | Plaque 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). | 24 and 36 months of age for children |
| Breastfeeding rate | Duration of breastfeeding (in months) | 12 and 24 months of age for children |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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