Clinical trial NCT02200536: Impact of Providing Free Preventive Dental Health Products on Infant's Tooth Brushing and Bottle-feeding Termination Practices
Official title: Effectiveness of an Oral Health Promotion Program in Infant's Tooth Brushing and Bottle-feeding Termination Practices: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant's Tooth Brushing
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 92
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria for infants:

* 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.

Primary outcomes:
measure: Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.
timeFrame: Baseline (T0) and after one month (T1)
Secondary outcomes:
measure: Change in Mother's Reported Bottle-feeding Practice.
timeFrame: Baseline (T0) and after one month (T1)
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Faculty of Dentistry
Study officials:
affiliation: Damascus Univeristy
name: Easter Joury, BDS, DOrth, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Damascus University
name: Muna Alghadban, BDS, MSc
role: PRINCIPAL_INVESTIGATOR
References: