Dental Caries in ChildrenNCT03478748
The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
A study testing Dental health education in people with Dental Caries in Children, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study aimed to compare the impact of anticipatory guidance on the caries incidence of 2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers' oral health literacy, as compared to the conventional Ministry of Health (MOH) programme. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Dental health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Jan 2015to 15 Dec 2017
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the age of 2-3 years old
- Older sibling aged 4 to 6 years categorized as having high caries risk based on a Caries Risk Assessment tool adapted from the American Association of Paediatric Dentistry
- Mothers who were willing to participate in the study
Who cannot join
- Medically compromised children
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to compare the impact of anticipatory guidance on the caries incidence of 2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers' oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.
Read the detailed description
This quasi-experimental study was conducted at two government dental clinics in Batu Pahat District, Malaysia. The samples comprised of 478 mother-child-sibling trios (233 families in the intervention group, and 245 families in the control group). An oral health package named the Family Dental Wellness Programme (FDWP) was designed to provide anticipatory guidance to the intervention group at six-month intervals over three years. The control group received the standard MOH oral health education activities. The impact of FDWP on net caries increment, caries prevented fraction, and mother's oral health literacy was assessed after three years of intervention.
- Conditions
- Dental Caries in Children
- Being tested
- Dental health education
- Keywords
- Dental caries, Oral health literacy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental health educationOther
Also called Anticipatory guidance
Anticipatory guidance given to mothers to promote their children's oral health.
| Study group | Role | What they receive |
|---|---|---|
| one-to-one dental health education | Active comparator | Conventional oral health education programme that mainly focuses at child level, which has been the normal practice at the Ministry of Health, were provided to the control participants. Receives: Other: Dental health education |
| anticipatory guidance technique | Experimental | Anticipatory guidance technique were applied where appropriate dental health education (according to the children's milestones) were provided to mothers and their children. Receives: Other: Dental health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dental caries
Change from baseline dental caries prevalence at 3 years using visual and tactile examination
Measured: Baseline and 3 years
Secondary outcomes (1)
Mothers' oral health literacy
Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments
Measured: Baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start2 Jan 2015
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
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 Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The model is an oral health education package that covers the following aspects: (i) cognitive component (for example, the provision of basic oral health knowledge using an anticipatory guidance technique); (ii) psychomotor component (for example, the demonstration of basic oral health skills such as toothbrushing skills with a hands-on practical); and (iii) attitude component (activities that help to improve the children's attitude towards oral health). Children (along with their older siblings and mothers) in the study group were required to make six-monthly visits to the dental clinic in the three-year study period. Those in the control group received the conventional Ministry of Health programme.
- Masking
- None (open label)
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norintan Ab Murat, University of Malaya
- Investigators
- Norintan Ab Murat, PhD, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478748
- Sponsor's protocol ID
- DFCO1505/0005P
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ismail A, Razak IA, Ab-Murat N. The impact of anticipatory guidance on early childhood caries: a quasi-experimental study. BMC Oral Health. 2018 Jul 27;18(1):126. doi: 10.1186/s12903-018-0589-0.
PubMed 30053849
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT03478748
- Acronym / sponsor ID
- DFCO1505/0005P
- Conditions
- Dental Caries in Children
- Keywords
- Dental caries, Oral health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 27 Mar 2018 (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.
This study aimed to compare the impact of anticipatory guidance on the caries incidence of 2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers' oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.
Detailed description
This quasi-experimental study was conducted at two government dental clinics in Batu Pahat District, Malaysia. The samples comprised of 478 mother-child-sibling trios (233 families in the intervention group, and 245 families in the control group). An oral health package named the Family Dental Wellness Programme (FDWP) was designed to provide anticipatory guidance to the intervention group at six-month intervals over three years. The control group received the standard MOH oral health education activities. The impact of FDWP on net caries increment, caries prevented fraction, and mother's oral health literacy was assessed after three years of intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The model is an oral health education package that covers the following aspects: (i) cognitive component (for example, the provision of basic oral health knowledge using an anticipatory guidance technique); (ii) psychomotor component (for example, the demonstration of basic oral health skills such as toothbrushing skills with a hands-on practical); and (iii) attitude component (activities that help to improve the children's attitude towards oral health). Children (along with their older siblings and mothers) in the study group were required to make six-monthly visits to the dental clinic in the three-year study period. Those in the control group received the conventional Ministry of Health programme.
| Arm | Type | Receives |
|---|---|---|
| one-to-one dental health education | Active comparator | Other: Dental health educationConventional oral health education programme that mainly focuses at child level, which has been the normal practice at the Ministry of Health, were provided to the control participants. |
| anticipatory guidance technique | Experimental | Other: Dental health educationAnticipatory guidance technique were applied where appropriate dental health education (according to the children's milestones) were provided to mothers and their children. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between the age of 2-3 years old
- Older sibling aged 4 to 6 years categorized as having high caries risk based on a Caries Risk Assessment tool adapted from the American Association of Paediatric Dentistry
- Mothers who were willing to participate in the study
Key exclusion criteria (1 listed)
- Medically compromised children
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 |
|---|---|---|
| Dental health educationAlso: Anticipatory guidanceAnticipatory guidance given to mothers to promote their children's oral health. | Other | anticipatory guidance technique, one-to-one dental health education |
Primary outcome
Incidence of dental caries
Time frame: Baseline and 3 years
Change from baseline dental caries prevalence at 3 years using visual and tactile examination
1 secondary outcome
Mothers' oral health literacy
Time frame: Baseline and 3 years
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 27 Mar 2018.
- Derived from this study: PubMed 30053849Ismail A, Razak IA, Ab-Murat N. The impact of anticipatory guidance on early childhood caries: a quasi-experimental study. BMC Oral Health. 2018 Jul 27;18(1):126. doi: 10.1186/s12903-018-0589-0.
- Individual participant dataSharing planned: No
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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.
Norintan Ab Murat, PhD study chair
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental health education in people with Dental Caries in Children, run by University of Malaya at 1 site in 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 3 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 27 Mar 2018. 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 Malaysia. 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?
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?
Incidence of dental caries (time frame: Baseline and 3 years). 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 NCT03478748, 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 27 Mar 2018.