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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
746

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gestational Age (Weeks)
Time Frame: At delivery
log[42.9-gestational age]
At delivery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Procter and Gamble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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