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Clinical Trials/NCT02922010
NCT02922010
Completed
Not Applicable

A Follow-Up Survey of Oral Hygiene and Health Outcomes of Women Enrolled in the "OHMOM" Clinical Trial at the University of Alabama Birmingham

Procter and Gamble1 site in 1 country35 target enrollmentJune 2016
ConditionsGingivitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingivitis
Sponsor
Procter and Gamble
Enrollment
35
Locations
1
Primary Endpoint
Löe-Silness Gingivitis Index
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 30, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Procter and Gamble
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Löe-Silness Gingivitis Index

Time Frame: 1 Day

Study Sites (1)

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