Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02200536
Enrollment
92
Registered
2014-07-25
Start date
2013-03-31
Completion date
2013-05-31
Last updated
2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant's Tooth Brushing

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.

Interventions

OTHERInfant 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.

OTHERInfant oral health pamphlet

Infant oral health pamphlet

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 12 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

MeasureTime frameDescription
Change in Mother's Reported Bottle-feeding Practice.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.

Countries

Syria

Participant flow

Participants by arm

ArmCount
Test
Infant oral health promotion package 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.
32
Control 1
Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet
30
Control 2
No intervention.
30
Total92

Baseline characteristics

CharacteristicTotalTestControl 1Control 2
Age, Customized
< 30 years old
48 participants21 participants14 participants13 participants
Age, Customized
≥ 30 years old
44 participants11 participants16 participants17 participants
Sex: Female, Male
Female
59 Participants19 Participants21 Participants19 Participants
Sex: Female, Male
Male
33 Participants13 Participants9 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

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.

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

ArmMeasureValue (NUMBER)
TestChange in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.90.6 percentage of mothers
Control 1Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.10 percentage of mothers
Control 2Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.6.7 percentage of mothers
Secondary

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.

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

ArmMeasureValue (NUMBER)
TestChange in Mother's Reported Bottle-feeding Practice.18.8 percentage of mothers
Control 1Change in Mother's Reported Bottle-feeding Practice.69.2 percentage of mothers
Control 2Change in Mother's Reported Bottle-feeding Practice.93.8 percentage of mothers

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026