Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

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.