Impact of Providing Free Preventive Dental Health Products on Infant's Tooth Brushing and Bottle-feeding Termination Practices

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.

Study Overview

• Status: Completed
• Conditions: Infant's Tooth Brushing
• Intervention / Treatment: Other: Infant oral health promotion package; Other: Infant oral health pamphlet

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Infant oral health promotion package	Other: 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.
Active Comparator: Control 1; Infant oral health pamphlet	Other: Infant oral health pamphlet; Infant oral health pamphlet
No Intervention: Control 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	Baseline (T0) and after one month (T1)

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Easter Joury, BDS, DOrth, MSc, PhD, Damascus Univeristy; Principal Investigator: Muna Alghadban, BDS, MSc, Damascus university

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: DM20AM18