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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

February 28, 2012
November 18, 2014
February 2012
April 2014   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT01549587 on ClinicalTrials.gov Archive Site
Gestational Age (weeks) [ Time Frame: At delivery ] [ Designated as safety issue: No ]
Not Provided
  • 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 ]
Not Provided
 
Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)
A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Gingivitis
  • Pregnancy
  • 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
  • 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
  • Active Comparator: Regular Oral Hygiene
    toothpaste, toothbrush and dental floss
    Interventions:
    • Drug: 0.243% sodium fluoride
    • Device: toothbrush
    • Device: dental floss
  • Experimental: Advanced Oral Hygiene plus counseling
    toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
    Interventions:
    • Drug: 0.454% stannous fluoride
    • Device: toothbrush
    • Drug: 0.07% Cetylpyridinium chloride
    • Device: dental floss
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
746
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01549587
2011001
Yes
Procter and Gamble
Procter and Gamble
Not Provided
Principal Investigator: Marjorie Jeffcoat, DMD School of Dentistry University of Pennsylvania
Principal Investigator: Michael Reddy, DMD, DMSc School of Dentistry University of Alabama
Procter and Gamble
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP