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A Follow-Up Survey of Oral Hygiene and Health Outcomes for Women Previously Enrolled in "OHMOM" (OHBABY)

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ClinicalTrials.gov Identifier: NCT02922010
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at University of Alabama Birmingham during the period 2012-2014. Additional objectives of the research include evaluation of possible cultural, biological or other mechanisms for outcomes observed in the OHMOM clinical trial, and oral health screening of children born to mothers during the study for the purposes of understanding possible multigenerational effects of oral hygiene education.

Condition or disease
Gingivitis

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: A Follow-Up Survey of Oral Hygiene and Health Outcomes of Women Enrolled in the "OHMOM" Clinical Trial at the University of Alabama Birmingham
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health




Primary Outcome Measures :
  1. Löe-Silness Gingivitis Index [ Time Frame: 1 Day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants from the OHMOM study and offspring from that study (NCT01549587) at the University of Alabama Birmingham.
Criteria

Inclusion Criteria:

  • be at least 18 years of age
  • sign an informed consent form and be given a copy
  • be a former subject in study 2011001 at University of Alabama Birmingham with a live birth outcome from that study.

Exclusion Criteria:

  • any medical condition requiring pre-medication prior to dental procedures
  • any diseases or conditions that might interfere with the subject safely completing the study
  • inability to undergo study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922010


Locations
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United States, Alabama
Center for Women's Reproductive Health
Birmingham, Alabama, United States, 35294-0024
Sponsors and Collaborators
Procter and Gamble
Investigators
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Study Director: Robert W Gerlach, DDS, MPH Procter and Gamble

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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02922010    
Other Study ID Numbers: 2015108
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases