Clinical trial NCT01549587: Oral Hygiene and Maternity Outcomes Multicenter Study (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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Pregnancy
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 746
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Löe-Silness Gingivitis Index
timeFrame: 3 months
measure: Change From Baseline in Löe-Silness Gingivitis Index
timeFrame: 2 months
measure: Change From Baseline in Löe-Silness Gingivitis Index
timeFrame: 1 month
Secondary outcomes:
measure: Gestational Age (Weeks)
timeFrame: At delivery
Other outcomes:
measure: Neonate Birth Weight (Grams)
timeFrame: At delivery
measure: Preterm Birth (Gestational Age < 37 Weeks)
timeFrame: At delivery
Locations:
city: Birmingham
country: United States
facility: Center for Women's Reproductive Health
state: Alabama
city: Philadelphia
country: United States
facility: Penn OB/Gyn and Associates
state: Pennsylvania
Study officials:
affiliation: School of Dentistry University of Pennsylvania
name: Marjorie Jeffcoat, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dentistry University of Alabama
name: Michael Reddy, DMD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: