Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

Procter & Gamble (P&G)

Status: Completed

Conditions: Pregnancy; Gingivitis

Treatments: Device: toothbrush; Device: dental floss; Drug: 0.243% sodium fluoride; Drug: 0.07% Cetylpyridinium chloride; Drug: 0.454% stannous fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01549587

2011001

Details and patient eligibility

About

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.

Enrollment: 746 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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746 participants in 2 patient groups

Regular Oral Hygiene

Active Comparator group

Description:

toothpaste, toothbrush and dental floss

Treatment:

Device: toothbrush

Device: dental floss

Drug: 0.243% sodium fluoride

Device: dental floss

Device: toothbrush

Advanced Oral Hygiene plus counseling

Experimental group

Description:

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

Treatment:

Device: toothbrush

Device: dental floss

Drug: 0.454% stannous fluoride

Drug: 0.07% Cetylpyridinium chloride

Device: dental floss

Device: toothbrush