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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BASIS program | Experimental | Prenatal and postnatal anticipatory guidance with home visits |
|
| Ministry of Health early childhood oral healthcare program | Active Comparator | Postnatal anticipatory guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticipatory guidance and postnatal home visits | Behavioral | Anticipatory guidance to pregnant women, followed by scheduled home visits at 6, 12, and 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the age of 6 month to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
• Diagnosed with cognitive disorders
This study enrolled pregnant women. Therefore, only females are eligible to participate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tudan Health Clinic | Miri | Sarawak | 98000 | Malaysia |
Ethical considerations
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Anticipatory guidance | Behavioral | Postnatal anticipatory guidance |
|
| From enrollment to the end of the intervention at 18 months postpartum |