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Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

NCT01549587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2023-04-21

Study results available
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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.

Conditions

  • Gingivitis
  • Pregnancy

Interventions

DRUG

0.243% sodium fluoride

dentifrice: brush thoroughly twice daily

DEVICE

toothbrush

brush thoroughly twice daily

DEVICE

dental floss

floss the whole mouth once daily

DRUG

0.454% stannous fluoride

dentifrice: twice daily brush thoroughly for 2 minutes

DEVICE

toothbrush

twice daily brush thoroughly for 2 minutes

DRUG

0.07% Cetylpyridinium chloride

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

DEVICE

dental floss

floss the whole mouth once daily

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Marjorie Jeffcoat, DMD · School of Dentistry University of Pennsylvania

  • Michael Reddy, DMD, DMSc · School of Dentistry University of Alabama

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549587 on ClinicalTrials.gov