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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Infant oral health promotion package |
|
| Control 1 | Active Comparator | Infant oral health pamphlet |
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| Control 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant oral health promotion package | Other | Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T0) and after one month (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for infants:
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| Name | Affiliation | Role |
|---|---|---|
| Easter Joury, BDS, DOrth, MSc, PhD | Damascus Univeristy | Study Director |
| Muna Alghadban, BDS, MSc | Damascus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Damascus | Syria |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Infant oral health promotion package Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup. |
| FG001 | Control 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Infant oral health pamphlet | Other | Infant oral health pamphlet |
|
| Baseline (T0) and after one month (T1) |
Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet |
| FG002 | Control 2 | No intervention. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Infant oral health promotion package Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup. |
| BG001 | Control 1 | Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet |
| BG002 | Control 2 | No intervention. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mother's age | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Infant's gender, Male/Female | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of mothers | Baseline (T0) and after one month (T1) |
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| Secondary | 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. | Posted | Number | percentage of mothers | Baseline (T0) and after one month (T1) |
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Serious or other [non-serious] adverse events were not collected in the current trial, as there were no previously identified adverse events in studies with the same type of interventions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | Infant oral health promotion package Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup. | 0 | 0 | 0 | 0 | ||
| EG001 | Control 1 | Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet | 0 | 0 | 0 | 0 | ||
| EG002 | Control 2 | No intervention. | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor Easter Joury | Damascus University | 00963955650456 | easterjoury@icloud.com |
| < 30 years old |
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| Male |
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| Counts |
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| Participants |
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