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NCT02922010 Clinical Trial

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

Gingivitis Clinical Trial

— OHBABY  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02922010
Other study ID # 2015108
Secondary ID
Status Completed
Phase N/A
First received September 29, 2016
Last updated September 18, 2017
Start date June 2016
Est. completion date June 30, 2017

Study information
Verified date September 2017
Source Procter and Gamble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Center for Women's Reproductive Health Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Löe-Silness Gingivitis Index 1 Day
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