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

NCT ID: NCT02200536

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-05-31

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.

Conditions

Infant's Tooth Brushing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Test

Infant oral health promotion package

Group Type: EXPERIMENTAL

Infant oral health promotion package

Intervention Type: OTHER

Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.

Control 1

Infant oral health pamphlet

Group Type: ACTIVE_COMPARATOR

Infant oral health pamphlet

Intervention Type: OTHER

Infant oral health pamphlet

Control 2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Infant oral health pamphlet

Infant oral health pamphlet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Easter Joury, BDS, DOrth, MSc, PhD

Role: STUDY_DIRECTOR

Damascus Univeristy

Muna Alghadban, BDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Damascus University

Locations

Faculty of Dentistry

Damascus, , Syria

Countries

Syria

Other Identifiers

DM20AM18

Identifier Type: -

Identifier Source: org_study_id