Trial Outcomes & Findings for Impact of Providing Free Preventive Dental Health Products on Infant's Tooth Brushing and Bottle-feeding Termination Practices (NCT NCT02200536)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

Baseline (T0) and after one month (T1)

Results posted on

2015-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Control 1 Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet	Control 2 No intervention.
Overall Study STARTED	32	30	30
Overall Study COMPLETED	32	30	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test n=32 Participants 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.	Control 1 n=30 Participants Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet	Control 2 n=30 Participants No intervention.	Total n=92 Participants Total of all reporting groups
Age, Customized ≥ 30 years old	11 participants n=5 Participants	16 participants n=7 Participants	17 participants n=5 Participants	44 participants n=4 Participants
Age, Customized < 30 years old	21 participants n=5 Participants	14 participants n=7 Participants	13 participants n=5 Participants	48 participants n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	59 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test n=32 Participants 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.	Control 1 n=30 Participants Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet	Control 2 n=30 Participants No intervention.
Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.	90.6 percentage of mothers	10 percentage of mothers	6.7 percentage of mothers

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test n=16 Participants 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.	Control 1 n=13 Participants Infant oral health pamphlet Infant oral health pamphlet: Infant oral health pamphlet	Control 2 n=16 Participants No intervention.
Change in Mother's Reported Bottle-feeding Practice.	18.8 percentage of mothers	69.2 percentage of mothers	93.8 percentage of mothers

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Professor Easter Joury

Damascus University

Phone: 00963955650456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place