Infant's Tooth BrushingNCT02200536
Impact of Providing Free Preventive Dental Health Products on Infant's Tooth Brushing and Bottle-feeding Termination Practices
A study testing Infant oral health promotion package and Infant oral health pamphlet in people with Infant's Tooth Brushing, run by Damascus University at 1 site in Syria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant's Tooth Brushing
- What is being tested?
- Infant oral health promotion package and Infant oral health pamphlet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSyria
- Study dates
- Mar 2013to May 2013
- Phase
- Interventional
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 12 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
- Single (not twins).
- Full-term (≥37 weeks).
- Birth weight ≥ 2500 g.
- Family size ≤3 children (including the infant).
- Their first tooth erupted.
- No reported tooth brushing practice.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Oral Health Promotion Program in Infant's Tooth Brushing and Bottle-feeding Termination Practices: a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Infant's Tooth Brushing
- Being tested
- Infant oral health promotion package, Infant oral health pamphlet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant oral health promotion packageOther
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 pamphletOther
Infant oral health pamphlet
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Infant oral health promotion package Receives: Other: Infant oral health promotion package |
| Control 1 | Active comparator | Infant oral health pamphlet Receives: Other: Infant oral health pamphlet |
| Control 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) and after one month (T1)
Secondary outcomes (1)
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.
Measured: Baseline (T0) and after one month (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infant's Tooth BrushingStudies 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
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Easter Joury, BDS, DOrth, MSc, PhD, Study director, Damascus UniveristyMuna Alghadban, BDS, MSc, Principal investigator, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200536
- Sponsor's protocol ID
- DM20AM18
- Status last verified
- Mar 2015
- First submitted
- 22 Jul 2014
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes