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Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT01549587
First received: February 28, 2012
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Gingivitis
Pregnancy
Drug: 0.243% sodium fluoride
Device: toothbrush
Device: dental floss
Drug: 0.454% stannous fluoride
Drug: 0.07% Cetylpyridinium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Change from Baseline in Löe-Silness Gingivitis Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Löe-Silness Gingivitis Index [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Löe-Silness Gingivitis Index [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gestational Age (weeks) [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Neonate Birth Weight (grams) [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Preterm Birth (gestational age < 37 weeks) [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Enrollment: 746
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regular Oral Hygiene
toothpaste, toothbrush and dental floss
Drug: 0.243% sodium fluoride
dentifrice: brush thoroughly twice daily
Other Name: Crest® Cavity Protection toothpaste
Device: toothbrush
brush thoroughly twice daily
Other Name: Oral-B® Indicator toothbrush, regular, soft
Device: dental floss
floss the whole mouth once daily
Other Name: Oral-B® Essentials dental floss
Experimental: Advanced Oral Hygiene plus counseling
toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
Drug: 0.454% stannous fluoride
dentifrice: twice daily brush thoroughly for 2 minutes
Other Name: Crest® Pro-Health toothpaste
Device: toothbrush
twice daily brush thoroughly for 2 minutes
Other Name: Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head
Drug: 0.07% Cetylpyridinium chloride
mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
Other Name: Crest® Pro-Health Multi-Protection Mouth Rinse
Device: dental floss
floss the whole mouth once daily
Other Name: Glide® Pro-Health Deep Clean dental floss

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549587

Locations
United States, Alabama
Center for Women's Reproductive Health
Birmingham, Alabama, United States, 35294-0024
United States, Pennsylvania
Penn OB/Gyn and Associates
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Procter and Gamble
Investigators
Principal Investigator: Marjorie Jeffcoat, DMD School of Dentistry University of Pennsylvania
Principal Investigator: Michael Reddy, DMD, DMSc School of Dentistry University of Alabama
  More Information

No publications provided

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT01549587     History of Changes
Other Study ID Numbers: 2011001
Study First Received: February 28, 2012
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Cetylpyridinium
Fluorides
Listerine
Sodium Fluoride
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014