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

Primary Purpose

Gingivitis, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.243% sodium fluoride
toothbrush
dental floss
0.454% stannous fluoride
toothbrush
0.07% Cetylpyridinium chloride
dental floss
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for Women's Reproductive Health
  • Penn OB/Gyn and Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regular Oral Hygiene

Advanced Oral Hygiene plus counseling

Arm Description

toothpaste, toothbrush and dental floss

toothpaste, toothbrush, mouth rinse and dental floss plus specialized education

Outcomes

Primary Outcome Measures

Change From Baseline in Löe-Silness Gingivitis Index
Score Criteria 0 Normal gingiva. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
Change From Baseline in Löe-Silness Gingivitis Index
Score Criteria 0 Normal gingiva. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
Change From Baseline in Löe-Silness Gingivitis Index
Score Criteria 0 Normal gingiva. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.

Secondary Outcome Measures

Gestational Age (Weeks)
log[42.9-gestational age]

Full Information

First Posted
February 28, 2012
Last Updated
April 20, 2023
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT01549587
Brief Title
Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)
Acronym
OHMOM
Official Title
A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Oral Hygiene
Arm Type
Active Comparator
Arm Description
toothpaste, toothbrush and dental floss
Arm Title
Advanced Oral Hygiene plus counseling
Arm Type
Experimental
Arm Description
toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
Intervention Type
Drug
Intervention Name(s)
0.243% sodium fluoride
Other Intervention Name(s)
Crest® Cavity Protection toothpaste
Intervention Description
dentifrice: brush thoroughly twice daily
Intervention Type
Device
Intervention Name(s)
toothbrush
Other Intervention Name(s)
Oral-B® Indicator toothbrush, regular, soft
Intervention Description
brush thoroughly twice daily
Intervention Type
Device
Intervention Name(s)
dental floss
Other Intervention Name(s)
Oral-B® Essentials dental floss
Intervention Description
floss the whole mouth once daily
Intervention Type
Drug
Intervention Name(s)
0.454% stannous fluoride
Other Intervention Name(s)
Crest® Pro-Health toothpaste
Intervention Description
dentifrice: twice daily brush thoroughly for 2 minutes
Intervention Type
Device
Intervention Name(s)
toothbrush
Other Intervention Name(s)
Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head
Intervention Description
twice daily brush thoroughly for 2 minutes
Intervention Type
Drug
Intervention Name(s)
0.07% Cetylpyridinium chloride
Other Intervention Name(s)
Crest® Pro-Health Multi-Protection Mouth Rinse
Intervention Description
mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
Intervention Type
Device
Intervention Name(s)
dental floss
Other Intervention Name(s)
Glide® Pro-Health Deep Clean dental floss
Intervention Description
floss the whole mouth once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Löe-Silness Gingivitis Index
Description
Score Criteria 0 Normal gingiva. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
Time Frame
3 months
Title
Change From Baseline in Löe-Silness Gingivitis Index
Description
Score Criteria 0 Normal gingiva. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
Time Frame
2 months
Title
Change From Baseline in Löe-Silness Gingivitis Index
Description
Score Criteria 0 Normal gingiva. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Gestational Age (Weeks)
Description
log[42.9-gestational age]
Time Frame
At delivery
Other Pre-specified Outcome Measures:
Title
Neonate Birth Weight (Grams)
Time Frame
At delivery
Title
Preterm Birth (Gestational Age < 37 Weeks)
Time Frame
At delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie Jeffcoat, DMD
Organizational Affiliation
School of Dentistry University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Reddy, DMD, DMSc
Organizational Affiliation
School of Dentistry University of Alabama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Women's Reproductive Health
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0024
Country
United States
Facility Name
Penn OB/Gyn and Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

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