Dental Caries in ChildrenNCT04885348
The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children
A study testing Intervention Group (Dental Home Visits + Dental Home Education Leaflets) in people with Dental Caries in Children, run by Ministry of Education, Malaysia.
Trial summary
Tooth decay affects 75% of Malaysian preschool children, most of which remain untreated. Untreated decay can cause pain, and impair nutritional status and physical growth. In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of early childhood caries. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Intervention Group (Dental Home Visits + Dental Home Education Leaflets)
- 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
- 329 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All the children age of 5 or 6-year-old with parents' consents to participate from these kindergartens will be included as the subjects of this study
Who cannot join
- -
About this study
Official title: The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children - a Randomised Controlled Trial
Tooth decay affects 75% of Malaysian preschool children, most of which remain untreated. Untreated decay can cause pain, and impair nutritional status and physical growth. In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of early childhood caries. The realistic management of these children would have been treatment under general anaesthesia or sedation, at considerable cost to the state, and distress to the children and families. The amount of dental disease in young children who have been referred to the hospital children's dentistry service for severe caries is disturbing, particularly given the fact that each district has a dental clinic and that the water is very likely to be fluoridated. It is unlikely that there will ever be enough dental clinics and dental practitioners to manage the amount of disease. Clearly, existing health services need to be supplemented with a population-based approach to promote child oral health. The investigators, therefore, propose a community trial study to investigate the effectiveness of a dental health visiting service for caries control in young children. It is likely that such a home-based intervention is influenced by the family dynamics in which the child lives. The investigators further propose to assess the cost-effectiveness of dental home visits (DHVs). Health economic evaluation can be used to assess health services to ensure there is cost-efficient resource allocation. Economic evaluation is defined as the comparative analysis of alternative courses of action in terms of both their costs and consequences. A health intervention is considered cost-effective when it produces acceptable costs and health benefits. Economic data are now recognized as important due to the fact that dental disease is very common and expensive for the health care system.
This study was conducted in collaboration with the National Oral Health of Pre-school Survey (NOHPS), in which a sub-sample will be followed up for two years. The NOHPS is a national survey of the oral health of 5-year-olds that takes place every 10 years.
This is a randomized controlled trial to assess the cost-effectiveness of home-based DHVs with families of children at high risk of caries in caries prevention compared to children receiving oral health information in the form of an education leaflet (ELs) alone. A collaborative project with the Oral Health Division (OHD) at the Ministry of Health is proposed. The OHD will provide access to a sub-sample from the National Oral Health Preschool Survey (NOHPS), with clinical dental health data.
- Conditions
- Dental Caries in Children
- Being tested
- Intervention Group (Dental Home Visits + Dental Home Education Leaflets), Control Group (Dental Home Education Leaflets)
- Keywords
- Dental Caries, Dental Health Home Visits, Young Children, Dental Decay
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group (Dental Home Visits + Dental Home Education Leaflets)Behavioural
No drugs were given in the Intervention. The intervention group received Dental Home Visits consisted of 6 monthly home visits by oral health therapists/dental home visitors where they deliver dental care advice to the parents for durations of approximately 30 minutes until follow-up at two years. Dental Home Education Leaflets (DHELs) and oral health messages were delivered through a personalized approach that avoids direct persuasion. These messages included information on daily tooth brushing with fluoride toothpaste, controlling dietary sugar intake, and the need for regular dental check-ups. The families were also be provided with information about local dental services available in their vicinity and how to access these services.
Control Group (Dental Home Education Leaflets)Behavioural
Only Dental Home Education Leaflets were provided every six months for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Dental Home Visits and Dental Home Education Leaflets | Experimental | Two trained dental home visitors made 6-monthly Dental Home Visits (DHVs) to families in the Intervention Group. Dental Home Education Leaflets (DHELs) and oral health messages were delivered through a personalized approach that avoids direct persuasion. Receives: Behavioral: Intervention Group (Dental Home Visits + Dental Home Education Leaflets); Behavioral: Control Group (Dental Home Education Leaflets) |
| Dental Home Education Leaflets | Active comparator | Only Dental Home Education Leaflets were provided every six months for 2 years. Receives: Behavioral: Control Group (Dental Home Education Leaflets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children developing new caries in deciduous molars.
The number of children developing caries in deciduous molars over the two years follow up.
Measured: 2 years
Number of in deciduous molars developing new caries.
New caries detected in deciduous molars at the cavitation stage.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study startJan 2017
- Primary completionMay 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Education, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Professor Allan Pau, Ministry of Education, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885348
- Sponsor's protocol ID
- IMU R 157/2014 (FRGS)
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheiham A. Dental caries affects body weight, growth and quality of life in pre-school children. Br Dent J. 2006 Nov 25;201(10):625-6. doi: 10.1038/sj.bdj.4814259.
PubMed 17128231M E Drummond, M J Sculpher, G W Torrance GW, et al. Oxford University Press, 2005. ISBN 0-19-852945-7
Masood M, Yusof N, Hassan MI, Jaafar N. Assessment of dental caries predictors in 6-year-old school children - results from 5-year retrospective cohort study. BMC Public Health. 2012 Nov 16;12:989. doi: 10.1186/1471-2458-12-989.
PubMed 23158416Seow WK. Biological mechanisms of early childhood caries. Community Dent Oral Epidemiol. 1998;26(1 Suppl):8-27. doi: 10.1111/j.1600-0528.1998.tb02090.x.
PubMed 9671196
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04885348
- Acronym / sponsor ID
- IMU R 157/2014 (FRGS)
- Conditions
- Dental Caries in Children
- Keywords
- Dental Caries, Dental Health Home Visits, Young Children, Dental Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Ministry of Education, MalaysiaOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 13 May 2021 (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.
Tooth decay affects 75% of Malaysian preschool children, most of which remain untreated. Untreated decay can cause pain, and impair nutritional status and physical growth. In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of early childhood caries. The realistic management of these children would have been treatment under general anaesthesia or sedation, at considerable cost to the state, and distress to the children and families. The amount of dental disease in young children who have been referred to the hospital children's dentistry service for severe caries is disturbing, particularly given the fact that each district has a dental clinic and that the water is very likely to be fluoridated. It is unlikely that there will ever be enough dental clinics and dental practitioners to manage the amount of disease. Clearly, existing health services need to be supplemented with a population-based approach to promote child oral health. The investigators, therefore, propose a community trial study to investigate the effectiveness of a dental health visiting service for caries control in young children. It is likely that such a home-based intervention is influenced by the family dynamics in which the child lives. The investigators further propose to assess the cost-effectiveness of dental home visits (DHVs). Health economic evaluation can be used to assess health services to ensure there is cost-efficient resource allocation. Economic evaluation is defined as the comparative analysis of alternative courses of action in terms of both their costs and consequences. A health intervention is considered cost-effective when it produces acceptable costs and health benefits. Economic data are now recognized as important due to the fact that dental disease is very common and expensive for the health care system.
This study was conducted in collaboration with the National Oral Health of Pre-school Survey (NOHPS), in which a sub-sample will be followed up for two years. The NOHPS is a national survey of the oral health of 5-year-olds that takes place every 10 years.
This is a randomized controlled trial to assess the cost-effectiveness of home-based DHVs with families of children at high risk of caries in caries prevention compared to children receiving oral health information in the form of an education leaflet (ELs) alone. A collaborative project with the Oral Health Division (OHD) at the Ministry of Health is proposed. The OHD will provide access to a sub-sample from the National Oral Health Preschool Survey (NOHPS), with clinical dental health data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Home Visits and Dental Home Education Leaflets | Experimental | Behavioral: Intervention Group (Dental Home Visits + Dental Home Education Leaflets), Behavioral: Control Group (Dental Home Education Leaflets)Two trained dental home visitors made 6-monthly Dental Home Visits (DHVs) to families in the Intervention Group. Dental Home Education Leaflets (DHELs) and oral health messages were delivered through a personalized approach that avoids direct persuasion. |
| Dental Home Education Leaflets | Active comparator | Behavioral: Control Group (Dental Home Education Leaflets)Only Dental Home Education Leaflets were provided every six months for 2 years. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All the children age of 5 or 6-year-old with parents' consents to participate from these kindergartens will be included as the subjects of this study
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Intervention Group (Dental Home Visits + Dental Home Education Leaflets)No drugs were given in the Intervention. The intervention group received Dental Home Visits consisted of 6 monthly home visits by oral health therapists/dental home visitors where they deliver dental care advice to the parents for durations of approximately 30 minutes until follow-up at two years. Dental Home Education Leaflets (DHELs) and oral health messages were delivered through a personalized approach that avoids direct persuasion. These messages included information on daily tooth brushing with fluoride toothpaste, controlling dietary sugar intake, and the need for regular dental check-ups. The families were also be provided with information about local dental services available in their vicinity and how to access these services. | Behavioural | Dental Home Visits and Dental Home Education Leaflets |
| Control Group (Dental Home Education Leaflets)Only Dental Home Education Leaflets were provided every six months for 2 years. | Behavioural | Dental Home Education Leaflets, Dental Home Visits and Dental Home Education Leaflets |
Primary outcome
Number of children developing new caries in deciduous molars.
Time frame: 2 years
The number of children developing caries in deciduous molars over the two years follow up.
Number of in deciduous molars developing new caries.
Time frame: 2 years
New caries detected in deciduous molars at the cavitation stage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 17128231Sheiham A. Dental caries affects body weight, growth and quality of life in pre-school children. Br Dent J. 2006 Nov 25;201(10):625-6. doi: 10.1038/sj.bdj.4814259.
- BackgroundM E Drummond, M J Sculpher, G W Torrance GW, et al. Oxford University Press, 2005. ISBN 0-19-852945-7
- Background: PubMed 23158416Masood M, Yusof N, Hassan MI, Jaafar N. Assessment of dental caries predictors in 6-year-old school children - results from 5-year retrospective cohort study. BMC Public Health. 2012 Nov 16;12:989. doi: 10.1186/1471-2458-12-989.
- Background: PubMed 9671196Seow WK. Biological mechanisms of early childhood caries. Community Dent Oral Epidemiol. 1998;26(1 Suppl):8-27. doi: 10.1111/j.1600-0528.1998.tb02090.x.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (Dental Home Visits + Dental Home Education Leaflets) in people with Dental Caries in Children, run by Ministry of Education, Malaysia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children developing new caries in deciduous molars. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT04885348, which also lists 4 linked publications.
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 26 May 2021.