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OpenTrials
Completed

NCT Number: NCT02200536

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

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.

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Key information

Conditions

Infant's Tooth Brushing

Age range

12 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Infant oral health pamphlet

Other

Infant oral health pamphlet

Primary outcomes

  1. Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.

    Time frame: Baseline (T0) and after one month (T1)

    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.

Secondary outcomes

  1. Change in Mother's Reported Bottle-feeding Practice.

    Time frame: Baseline (T0) and after one month (T1)

    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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Effectiveness of an Oral Health Promotion Program in Infant's Tooth Brushing and Bottle-feeding Termination Practices: a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2014
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.