Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

Not Applicable

Completed

• Conditions: Gingivitis; Pregnancy
• Interventions: Drug: 0.454% stannous fluoride; Drug: 0.243% sodium fluoride; Device: toothbrush; Drug: 0.07% Cetylpyridinium chloride; Device: dental floss

• Registration Number: NCT01549587
• Lead Sponsor: Procter and Gamble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Results First Submitted: 2020-08-31
• Results First Submitted QC: 2020-09-22
• Results First Posted: 2020-10-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 746

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advanced Oral Hygiene plus counseling	0.07% Cetylpyridinium chloride	toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
Regular Oral Hygiene	dental floss	toothpaste, toothbrush and dental floss
Advanced Oral Hygiene plus counseling	0.454% stannous fluoride	toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
Regular Oral Hygiene	0.243% sodium fluoride	toothpaste, toothbrush and dental floss
Advanced Oral Hygiene plus counseling	toothbrush	toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
Regular Oral Hygiene	toothbrush	toothpaste, toothbrush and dental floss
Advanced Oral Hygiene plus counseling	dental floss	toothpaste, toothbrush, mouth rinse and dental floss plus specialized education

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Löe-Silness Gingivitis Index	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.

Secondary Outcome Measures

Name	Time	Method
Gestational Age (Weeks)	At delivery	log\[42.9-gestational age\]

Trial Locations

Locations (2)

Penn OB/Gyn and Associates; 🇺🇸 Philadelphia, Pennsylvania, United States

Center for Women's Reproductive Health; 🇺🇸 Birmingham, Alabama, United States