Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM) (OHMOM)

April 20, 2023 updated by: Procter and Gamble

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

746

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0024
        • Center for Women's Reproductive Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn OB/Gyn and Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • be at least the age of legal consent;
  • be between 8 and 24 weeks of pregnancy;
  • have at least 20 natural teeth;
  • have moderate-to-severe gingivitis during pregnancy, including at least 30 intraoral sites with evidence of marginal gingival bleeding.

Exclusion Criteria:

  • evidence of multiple gestations;
  • history of HIV infection, AIDS, autoimmune disease, or diabetes other than gestational diabetes;
  • indication for use of antibiotic pre-medication prior to dental procedures;
  • systemic corticosteroid or immunosuppressive therapy within 1 month of Baseline;
  • severe periodontal disease, rampant untreated dental caries, or other oral conditions that necessitate immediate dental care;
  • ongoing dental care that in the opinion of the investigator could impact study participation;
  • a history of allergies or hypersensitivity to mouth rinse products containing CPC;
  • any disease or condition that in the opinion of the investigator could interfere with the safe completion of the study;
  • randomization to a treatment in study 2011001 during a prior pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Regular Oral Hygiene
toothpaste, toothbrush and dental floss
Drug: 0.243% sodium fluoride
dentifrice: brush thoroughly twice daily
Other Names:
  • Crest® Cavity Protection toothpaste
Device: toothbrush
brush thoroughly twice daily
Other Names:
  • Oral-B® Indicator toothbrush, regular, soft
Device: dental floss
floss the whole mouth once daily
Other Names:
  • Glide® Pro-Health Deep Clean dental floss
Device: toothbrush
twice daily brush thoroughly for 2 minutes
Other Names:
  • Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head
Experimental: Advanced Oral Hygiene plus counseling
toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
Device: toothbrush
brush thoroughly twice daily
Other Names:
  • Oral-B® Indicator toothbrush, regular, soft
Device: dental floss
floss the whole mouth once daily
Other Names:
  • Glide® Pro-Health Deep Clean dental floss
Device: toothbrush
twice daily brush thoroughly for 2 minutes
Other Names:
  • Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head
Drug: 0.454% stannous fluoride
dentifrice: twice daily brush thoroughly for 2 minutes
Other Names:
  • Crest® Pro-Health toothpaste
Drug: 0.07% Cetylpyridinium chloride
mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
Other Names:
  • Crest® Pro-Health Multi-Protection Mouth Rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Löe-Silness Gingivitis Index
Time Frame: 3 months

Score Criteria 0 Normal gingiva.

  1. Mild inflammation - slight change in color, slight edema. No bleeding on probing.
  2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing.
  3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
3 months
Change From Baseline in Löe-Silness Gingivitis Index
Time Frame: 2 months

Score Criteria 0 Normal gingiva.

  1. Mild inflammation - slight change in color, slight edema. No bleeding on probing.
  2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing.
  3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
2 months
Change From Baseline in Löe-Silness Gingivitis Index
Time Frame: 1 month

Score Criteria 0 Normal gingiva.

  1. Mild inflammation - slight change in color, slight edema. No bleeding on probing.
  2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing.
  3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational Age (Weeks)
Time Frame: At delivery
log[42.9-gestational age]
At delivery

Other Outcome Measures

Outcome Measure
Time Frame
Neonate Birth Weight (Grams)
Time Frame: At delivery
At delivery
Preterm Birth (Gestational Age < 37 Weeks)
Time Frame: At delivery
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

  • Principal Investigator: Marjorie Jeffcoat, DMD, School of Dentistry University of Pennsylvania
  • Principal Investigator: Michael Reddy, DMD, DMSc, School of Dentistry University of Alabama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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