CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 746 enrolled
Drug / intervention
0.243% sodium fluoride +6 moredrug
Likely dose
0.07% Cetylpyridinium chloride 20 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01549587
NCT01549587N/ACompleted
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A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes

Procter and Gamble·interventional·Posted Mar 9, 2012·Updated Apr 21, 2023

In Brief

A clinical study evaluating 0.243% sodium fluoride, toothbrush, and 3 other interventions for Gingivitis and Pregnancy. Completed, enrolled 746 participants across 2 sites.

Detailed Summary

This study will track changes in oral health in pregnant women. Subjects will be assigned to either regular oral care or advanced oral care and be given oral care products to use until they deliver. A comparison between the two groups (regular and advanced oral care) will be made to see if the oral care products impacted oral health and maternity variables.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGingivitis, Pregnancy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2012
Enrollment StartFeb 1, 2012
Primary CompletionFeb 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.3 years ago

Interventions

0.243% sodium fluoridedrug

dentifrice: brush thoroughly twice daily

toothbrushdevice

brush thoroughly twice daily

dental flossdevice

floss the whole mouth once daily

0.454% stannous fluoridedrug

dentifrice: twice daily brush thoroughly for 2 minutes

toothbrushdevice

twice daily brush thoroughly for 2 minutes

0.07% Cetylpyridinium chloridedrug

mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily

dental flossdevice

floss the whole mouth once daily