Dental CariesNCT06944977
Early Childhood Caries Prevention: Effectiveness of Mother-Child Oral Health Care Programme (BASIS)
A study testing Anticipatory guidance and postnatal home visits and Anticipatory guidance in people with Dental Caries, run by NORKHAFIZAH SADDKI at 1 site in Malaysia.
Trial summary
The goal of this two-arm, parallel-group cluster randomized controlled trial was to assess the effectiveness of the mother-child initiated oral health care program, termed BASIS, in preventing early childhood caries (ECC). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dental Caries
- What is being tested?
- Anticipatory guidance and postnatal home visits and Anticipatory guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Oct 2021to 8 Feb 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First-time pregnant women
- Aged 18 years and above
- In their third trimester
- Singleton pregnancy
- Able to read and write in Malay language
- Own a mobile phone with WhatsApp
- Will be the primary caretaker of their newborn
Who cannot join
- Diagnosed with cognitive disorders
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this two-arm, parallel-group cluster randomized controlled trial was to assess the effectiveness of the mother-child initiated oral health care program, termed BASIS, in preventing early childhood caries (ECC).
The main questions it aims to answer are:
Read more
- To compare mean knowledge and attitudes scores in the prevention of ECC among mothers of toddlers in the study group before and after receiving the BASIS program.
- To compare mean knowledge and attitude scores in the prevention of ECC between mothers of toddlers in the study group after receiving the BASIS program and mothers of toddlers in the control group after receiving the current Ministry of Health (MOH) programs.
- To compare oral health care practices in the prevention of ECC between mothers in the study group after receiving the BASIS program and mothers in the control group after receiving the current MOH program.
- To compare caries incidence between toddlers in the study group and toddlers in the control group after mothers' exposure to the BASIS program and the current MOH program, respectively.
Researchers will compare the BASIS program to the MOH program to see if the BASIS is effective to prevent ECC.
Participants of the BASIS program:
- Received anticipatory guidance delivered during pregnancy and after given birth at 6 months and 12 months
- Complete self-administered questionnaires measuring the knowledge, attitudes and practices related to the prevention of ECC during pregnancy and after given birth at 6 months, 12 months and 18 months
- Have their child oral cavity clinically examined at 6 months, 12 months and 18 months
- Conditions
- Dental Caries
- Being tested
- Anticipatory guidance and postnatal home visits, Anticipatory guidance
- Keywords
- anticipatory guidance, home visit, early childhood caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipatory guidance and postnatal home visitsBehavioural
Anticipatory guidance to pregnant women, followed by scheduled home visits at 6, 12, and 18 months
Anticipatory guidanceBehavioural
Postnatal anticipatory guidance
| Study group | Role | What they receive |
|---|---|---|
| BASIS program | Experimental | Prenatal and postnatal anticipatory guidance with home visits Receives: Behavioral: Anticipatory guidance and postnatal home visits |
| Ministry of Health early childhood oral healthcare program | Active comparator | Postnatal anticipatory guidance Receives: Behavioral: Anticipatory guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dental caries experience of the children from the age of 6 month to 18 months
All surfaces of the four upper and lower front teeth of the children were examined at three time points: when the child reached 6 months old, 12 months old, and 18 months old. A sound tooth with no evidence of caries was coded as 0, while a tooth with evidence of caries, whether non-cavitated (such as white or brown spot lesions) or cavitated, was coded as 1.
Measured: From the age of 6 month to 18 months
Secondary outcomes (1)
Change in knowledge, attitudes, and practices of mothers regarding the prevention of ECC assessed by self-administered questionnaire from enrollment to the end of the intervention at 18 months postpartum
The knowledge section of the questionnaire includes 30 items with responses in a close-ended format (true, false, and do not know). Correct answers receive 1 mark, while incorrect and 'do not know' responses receive no marks, resulting in a total score ranging from 0 to 30, with higher scores indicating better knowledge. The attitude domain consists of 12 items rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with negatively worded statements re-coded in reverse. The total attitude scores range from 12 to 60, with higher scores reflecting a more positive attitude. The practices domain includes 21 items, with most questions using a yes or no response. Two items-feeding the child sweet food and cleaning the child's mouth/teeth in a day in a week-are assessed on a frequency scale. Responses for each practice item are described in terms of frequency and percentage, rather than being numerically scored and summed.
Measured: From enrollment to the end of the intervention at 18 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start15 Oct 2021
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORKHAFIZAH SADDKI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NORKHAFIZAH SADDKI, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944977
- Sponsor's protocol ID
- IRB00010568
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical considerations
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Caries Prevention: Effectiveness of Mother-Child Oral Health Care Programme (BASIS)
- ClinicalTrials.gov ID
- NCT06944977
- Acronym / sponsor ID
- IRB00010568
- Conditions
- Dental Caries
- Keywords
- anticipatory guidance, home visit, early childhood caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- NORKHAFIZAH SADDKIUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 25 Apr 2025 (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.
The goal of this two-arm, parallel-group cluster randomized controlled trial was to assess the effectiveness of the mother-child initiated oral health care program, termed BASIS, in preventing early childhood caries (ECC).
The main questions it aims to answer are:
- To compare mean knowledge and attitudes scores in the prevention of ECC among mothers of toddlers in the study group before and after receiving the BASIS program.
- To compare mean knowledge and attitude scores in the prevention of ECC between mothers of toddlers in the study group after receiving the BASIS program and mothers of toddlers in the control group after receiving the current Ministry of Health (MOH) programs.
- To compare oral health care practices in the prevention of ECC between mothers in the study group after receiving the BASIS program and mothers in the control group after receiving the current MOH program.
- To compare caries incidence between toddlers in the study group and toddlers in the control group after mothers' exposure to the BASIS program and the current MOH program, respectively.
Researchers will compare the BASIS program to the MOH program to see if the BASIS is effective to prevent ECC.
Participants of the BASIS program:
- Received anticipatory guidance delivered during pregnancy and after given birth at 6 months and 12 months
- Complete self-administered questionnaires measuring the knowledge, attitudes and practices related to the prevention of ECC during pregnancy and after given birth at 6 months, 12 months and 18 months
- Have their child oral cavity clinically examined at 6 months, 12 months and 18 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASIS program | Experimental | Behavioral: Anticipatory guidance and postnatal home visitsPrenatal and postnatal anticipatory guidance with home visits |
| Ministry of Health early childhood oral healthcare program | Active comparator | Behavioral: Anticipatory guidancePostnatal anticipatory guidance |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- First-time pregnant women
- Aged 18 years and above
- In their third trimester
- Singleton pregnancy
- Able to read and write in Malay language
Key exclusion criteria (1 listed)
- Diagnosed with cognitive disorders
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 |
|---|---|---|
| Anticipatory guidance and postnatal home visitsAnticipatory guidance to pregnant women, followed by scheduled home visits at 6, 12, and 18 months | Behavioural | BASIS program |
| Anticipatory guidancePostnatal anticipatory guidance | Behavioural | Ministry of Health early childhood oral healthcare program |
Primary outcome
Changes in dental caries experience of the children from the age of 6 month to 18 months
Time frame: From the age of 6 month to 18 months
All surfaces of the four upper and lower front teeth of the children were examined at three time points: when the child reached 6 months old, 12 months old, and 18 months old. A sound tooth with no evidence of caries was coded as 0, while a tooth with evidence of caries, whether non-cavitated (such as white or brown spot lesions) or cavitated, was coded as 1.
1 secondary outcome
Change in knowledge, attitudes, and practices of mothers regarding the prevention of ECC assessed by self-administered questionnaire from enrollment to the end of the intervention at 18 months postpartum
Time frame: From enrollment to the end of the intervention at 18 months postpartum
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 25 Apr 2025.
- Individual participant dataSharing planned: No. Ethical considerations
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipatory guidance and postnatal home visits and Anticipatory guidance in people with Dental Caries, run by NORKHAFIZAH SADDKI 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 7 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 25 Apr 2025. 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?
Changes in dental caries experience of the children from the age of 6 month to 18 months (time frame: From the age of 6 month to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2025.