Early Childhood CariesMOHNCT06000293
Effectiveness of Strengthened Anticipatory Guidance Used in the MOH Malaysia Infant Oral Health Care Programme
A study testing Oral health education in people with Early Childhood Caries and Knowledge, Attitudes, Practice, run by Universiti Sains Malaysia.
Trial summary
This study aimed to assess the effectiveness of strengthened anticipatory guidance (AG) used in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC) lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's knowledge and practice on infant oral… Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries, Knowledge, Attitudes, Practice
- What is being tested?
- Oral health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Feb 2024
- 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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The infant and primary caregivers (parents/ caregivers) are a Malaysian citizen
- Primary caregivers can read and understand Bahasa Malaysia. This is because the AG will be conducted in Bahasa Malaysia, and the questionnaires are also in Bahasa Malaysia.
Who cannot join
- Infants with special needs, chronic diseases or conditions (e.g., stunting, failure to thrive and low birth weight) who are at risk for oral problems (e.g., higher risk of caries due to presence of hypomineralisation and hyperplasia) and require special oral health care.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Strengthened Anticipatory Guidance Used in the Ministry of Health Malaysia Infant Oral Health Care Programme: A Cluster Randomised Control Trial
This study aimed to assess the effectiveness of strengthened anticipatory guidance (AG) used in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC) lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's knowledge and practice on infant oral healthcare
Read the detailed description
This randomised control trial study will be conducted at six government Maternal and Child Health Clinics (MCHCs) in Negeri Sembilan District, Malaysia. The samples comprised of 220 primary caregivers-infant pairs (110 pairs in the intervention group, and 110 pairs in the control group). A strengthened infant oral health module named the Oral Health Infant Module Anticipatory Guidance (OHIM AG) was designed to provide anticipatory guidance to the intervention group at three-month intervals over 6 months. The control group will receive the conventional Ministry of Health Anticipatory Guidance (MOH AG). The effectiveness of OHIM AG on early signs of childhood caries lesions development, caries risk of infants, and primary caregivers's knowledge and practice on infant oral healthcare will be assessed after six months of intervention.
- Being tested
- Oral health education
- Keywords
- Early Childhood Caries, Knowledge, Practice
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral health educationOther
Also called Dental health education
Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | At baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 6-9 months old infants.
Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 9-12 months old infants.
After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old. Receives: Other: Oral health education |
| Control Group | No intervention | At baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will be allowed to receive the conventional MOH AG given by oral healthcare providers from the nearest dental clinic. Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old. After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early dental caries lesion and dental caries risk exposure among infants
The prevalence of early dental caries lesion and dental caries risk exposure between infants in the intervention and control groups.
Measured: 6 months
Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers)
The knowledge and practice score on infant oral health care between primary caregivers in the intervention and control groups.
The response options for knowledge items are true, false and don't know. A score of 1 will be given to correct answers and a score of 0 for incorrect and don't know answers. A higher score indicates better knowledge.
Each practice item is given 4 response options, including a never. The remaining three responses will include one correct or appropriate practice and two incorrect or inappropriate responses. A score of 1 will be given for the correct or appropriate answers, and a score of 0 will be given for inaccurate or inappropriate and never answers. A higher score indicates better practice.
In addition to individual domain scores, an overall score for knowledge and practice on infant oral health care can be determined by dividing the summed score from knowledge and practice domains by the total possible score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munalizaini binti Mukhtar, Universiti Sains Malaysia
- Investigators
- Munalizaini Mukhtar, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000293
- Sponsor's protocol ID
- USM/JEPeM/KK/23020194
- Other IDs
- NMRR ID-23-00845-JXN (IIR)
- Acronym
- MOH
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data obtained from this study will be published for knowledge purposes and will be presented as grouped data and thus will not identify the respondents individually. The data of subjects will be kept private and confidential for up to about five years after this study is completed and will be destroyed. Subjects can write to the investigators to request access to study findings. The data will not be disclosed to any parties working on this project unrelated to this study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Strengthened Anticipatory Guidance Used in the Ministry of Health Malaysia Infant Oral Health Care Programme: A Cluster Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06000293
- Acronym / sponsor ID
- MOH / USM/JEPeM/KK/23020194
- Keywords
- Early Childhood Caries, Knowledge, Practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 21 Aug 2023 (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 assess the effectiveness of strengthened anticipatory guidance (AG) used in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC) lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's knowledge and practice on infant oral healthcare
Detailed description
This randomised control trial study will be conducted at six government Maternal and Child Health Clinics (MCHCs) in Negeri Sembilan District, Malaysia. The samples comprised of 220 primary caregivers-infant pairs (110 pairs in the intervention group, and 110 pairs in the control group). A strengthened infant oral health module named the Oral Health Infant Module Anticipatory Guidance (OHIM AG) was designed to provide anticipatory guidance to the intervention group at three-month intervals over 6 months. The control group will receive the conventional Ministry of Health Anticipatory Guidance (MOH AG). The effectiveness of OHIM AG on early signs of childhood caries lesions development, caries risk of infants, and primary caregivers's knowledge and practice on infant oral healthcare will be assessed after six months of intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Oral health educationAt baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 6-9 months old infants. Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 9-12 months old infants. After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old. |
| Control Group | No intervention | –At baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will be allowed to receive the conventional MOH AG given by oral healthcare providers from the nearest dental clinic. Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old. After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The infant and primary caregivers (parents/ caregivers) are a Malaysian citizen
- Primary caregivers can read and understand Bahasa Malaysia. This is because the AG will be conducted in Bahasa Malaysia, and the questionnaires are also in Bahasa Malaysia.
Key exclusion criteria (1 listed)
- Infants with special needs, chronic diseases or conditions (e.g., stunting, failure to thrive and low birth weight) who are at risk for oral problems (e.g., higher risk of caries due to presence of hypomineralisation and hyperplasia) and require special oral health care.
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 |
|---|---|---|
| Oral health educationAlso: Dental health educationAnticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group | Other | Treatment Group |
Primary outcome
Early dental caries lesion and dental caries risk exposure among infants
Time frame: 6 months
The prevalence of early dental caries lesion and dental caries risk exposure between infants in the intervention and control groups.
Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers)
Time frame: 6 months
The knowledge and practice score on infant oral health care between primary caregivers in the intervention and control groups. The response options for knowledge items are true, false and don't know. A score of 1 will be given to correct answers and a score of 0 for incorrect and don't know answers. A higher score indicates better knowledge. Each practice item is given 4 response options, including a never. The remaining three responses will include one correct or appropriate practice and two incorrect or inappropriate responses. A score of 1 will be given for the correct or appropriate answers, and a score of 0 will be given for inaccurate or inappropriate and never answers. A higher score indicates better practice. In addition to individual domain scores, an overall score for knowledge and practice on infant oral health care can be determined by dividing the summed score from knowledge and practice domains by the total possible score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No. Data obtained from this study will be published for knowledge purposes and will be presented as grouped data and thus will not identify the respondents individually. The data of subjects will be kept private and confidential for up to about five years after this study is completed and will be destroyed. Subjects can write to the investigators to request access to study findings. The data will not be disclosed to any parties working on this project unrelated to this study.
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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.
Munalizaini Mukhtar principal investigator
Universiti Sains Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing Oral health education in people with Early Childhood Caries and Knowledge, Attitudes, Practice, run by Universiti Sains 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 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Munalizaini Mukhtar (+60136636632, munalizaini2020@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early dental caries lesion and dental caries risk exposure among infants (time frame: 6 months). 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?
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 23 Aug 2023.