An interventional study of Infant oral health promotion package and Infant oral health pamphlet in Infant's Tooth Brushing, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 12 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-27.
Sponsored by Damascus University · Not applicable, Interventional, and Prevention
Governmental initiatives (such as Sure Start in the UK) have integrated an oral health promotion intervention within their maternal and child health program and delivered dental education and enabling resources (a gift bag including a baby toothbrush, fluoride toothpaste and a trainer cup) to infant's mothers. Whilst this approach has minimal financial implications of human resources, no evidence exists regarding its effectiveness in establishing desirable infant's oral health behaviours. In Syria, there is a great need for developing an infant's oral health promotion program to promote oral hygiene practice, provide access to fluoride and terminate bottle-feeding practice. Thus, the current study aimed to test the effectiveness of an integrated infant's oral health promotion intervention within the Syrian national immunization program, which delivered printed dental education materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in establishing one-year old infant's oral hygiene and bottle-feeing termination practices.
The current randomized controlled trail allocated 92 one-year old infants, attending a maternal and child health center in Sweida city-Syria, to receive their vaccination, into three groups: test, control 1 and control 2. The test group received an infant oral health promotion package including a child oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup. Control 1 received only an infant pamphlet, whilst Control 2 received no intervention. A mother's self-completed structured questionnaire and an infant's clinical examination were completed and performed, at baseline and after one month, to assess tooth brushing and bottle-feeding practices as well as the presence of old plaque on infant's primary teeth, respectively.
Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for infants:
Infant oral health promotion package
Other: Infant oral health promotion package
Infant oral health pamphlet
Other: Infant oral health pamphlet
Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.
Infant oral health pamphlet
Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.
Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.
Time frame: Baseline (T0) and after one month (T1)
Change in Mother's Reported Bottle-feeding Practice.
Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.
Time frame: Baseline (T0) and after one month (T1)
| Milestone | Test | Control 1 | Control 2 |
|---|---|---|---|
| Started | 32 | 30 | 30 |
| Completed | 32 | 30 | 30 |
| Not completed | 0 | 0 | 0 |
Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.
| percentage of mothers | Test | Control 1 | Control 2 |
|---|---|---|---|
| Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice. | 90.6 | 10 | 6.7 |
Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.
| percentage of mothers | Test | Control 1 | Control 2 |
|---|---|---|---|
| Change in Mother's Reported Bottle-feeding Practice. | 18.8 | 69.2 | 93.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | — | — | — |
| Control 1 | — | — | — |
| Control 2 | — | — | — |
| Age, Customized(participants) | Test | Control 1 | Control 2 | Total |
|---|---|---|---|---|
| ≥ 30 years old | 11 | 16 | 17 | 44 |
| < 30 years old | 21 | 14 | 13 | 48 |
| Sex: Female, Male(Participants) | Test | Control 1 | Control 2 | Total |
|---|---|---|---|---|
| Female | 19 | 21 | 19 | 59 |
| Male | 13 | 9 | 11 | 33 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Damascus University