Dental CariesNCT06558955
Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries
A study testing Technology-enabled anticipatory guidance and peer support and Conventional health education in people with Dental Caries and Dental Caries in Children, run by National University of Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Caries in Children, Diet Habit
- What is being tested?
- Technology-enabled anticipatory guidance and peer support and Conventional health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Jun 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Zubair Amin, 67725075, paeza@nus.edu.sg
About this study
Official title: Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Dental Caries, Dental Caries in Children, Diet Habit
- Being tested
- Technology-enabled anticipatory guidance and peer support, Conventional health education
- Keywords
- Anticipatory Guidance, Peer Support, Oral Health, Technology, Dental Caries
- Medical subject headings
- Dental Caries, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-enabled anticipatory guidance and peer supportBehavioural
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.
Conventional health educationBehavioural
Participants on this arm will receive conventional child oral health education materials at 4 time points.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Conventional health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early childhood caries
Number of new surfaces with coronal caries
Measured: 24 and 36 months of age for children
Secondary outcomes (7)
Toothbrushing behaviours
Using a questionnaire, toothbrushing behaviours will be categorised as:
- Favourable (frequency of brushing >=2times/day)
- Unfavourable (frequency of brushing <2times/day)
Measured: 12, 24 and 36 months of age for children
Dietary and feeding practices (favourable/unfavourable)
Self-reported frequency of snack, sweet/dessert and sugary drink intake
Measured: 12, 24 and 36 months of age for children
Dental Utilisation
Self-reported frequency of dental visits
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 24 and 36 months of age for children
Breastfeeding rate
Duration of breastfeeding (in months)
Measured: 12 and 24 months of age for children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xiaoli, National University of Singapore
- Investigators
- Xiaoli Gao, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558955
- Sponsor's protocol ID
- DSRB 2024/00244
- Other IDs
- PHRGOC23jul-0011
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39633367
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06558955
- Acronym / sponsor ID
- DSRB 2024/00244
- Conditions
- Dental Caries, Dental Caries in Children, Diet Habit
- Keywords
- Anticipatory Guidance, Peer Support, Oral Health, Technology, Dental Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-enabled anticipatory guidance and peer support | Experimental | Behavioral: Technology-enabled anticipatory guidance and peer supportParticipants (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. |
| Conventional oral health education | Active comparator | Behavioral: Conventional health educationParticipants (mothers) will receive child oral health information for about 4 times (around 3, 6, 12, and 18 months of child's age). |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-enabled anticipatory guidance and peer supportThe 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. | Behavioural | Technology-enabled anticipatory guidance and peer support |
| Conventional health educationParticipants on this arm will receive conventional child oral health education materials at 4 time points. | Behavioural | Conventional oral health education |
Primary outcome
Incidence of early childhood caries
Time frame: 24 and 36 months of age for children
Number of new surfaces with coronal caries
7 secondary outcomes
Toothbrushing behaviours
Time frame: 12, 24 and 36 months of age for children
Dietary and feeding practices (favourable/unfavourable)
Time frame: 12, 24 and 36 months of age for children
Dental Utilisation
Time frame: 12, 24 and 36 months of age for children
Dental Costs
Time frame: 12, 24 and 36 months of age for children
Parental efficacy in managing oral health of child
Time frame: 12, 24 and 36 months of age for children
Plaque score
Time frame: 24 and 36 months of age for children
Breastfeeding rate
Time frame: 12 and 24 months of age for children
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 39633367Gao 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.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoli Gao, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-enabled anticipatory guidance and peer support and Conventional health education in people with Dental Caries and Dental Caries in Children, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Gao, PhD ((65) 6772 4990, dengx@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early childhood caries (time frame: 24 and 36 months of age for children). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.