Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02200536
Recruitment Status : Completed
First Posted : July 25, 2014
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
Damascus University

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.

Condition or disease Intervention/treatment Phase
Infant's Tooth Brushing Other: Infant oral health promotion package Other: Infant oral health pamphlet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of an Oral Health Promotion Program in Infant's Tooth Brushing and Bottle-feeding Termination Practices: a Randomized Controlled Trial
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200536


Locations
Layout table for location information
Syrian Arab Republic
Faculty of Dentistry
Damascus, Syrian Arab Republic
Sponsors and Collaborators
Damascus University
Investigators
Layout table for investigator information
Study Director: Easter Joury, BDS, DOrth, MSc, PhD Damascus Univeristy
Principal Investigator: Muna Alghadban, BDS, MSc Damascus University

Layout table for additonal information
Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02200536     History of Changes
Other Study ID Numbers: DM20AM18
First Posted: July 25, 2014    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015
Last Verified: March 2015