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A Study to Evaluate Associations Between Gingivitis and Pregnancy Outcomes

NCT00641901 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2013-03-01

No results posted yet for this study

Summary

Compelling evidence suggesting a possible link between maternal pregnancy-related periodontitis (gum disease) and spontaneous pre-term birth (PTB)makes effective management of oral health a relevant and significant obstetrical-dental issue.

The purpose of this pilot study is to determine whether intensive education and counseling can help pregnant women learn to maintain excellent oral health and in doing so reduce the severity of gingivitis and periodontitis during their pregnancy. Failure to effectively remove the plaque biofilm from the surface of teeth every day is the crucial event leading to the development of gingivitis and plaque-induced gingivitis is the most common form of periodontal disease in pregnant women.

We therefore hypothesize that patients can be taught to effectively modulate their own disease through intensive education and meticulous home care coupled with closely monitored behavior modification.

We believe this may be an effective approach toward improving oral health with the potential to reduce adverse pregnancy outcomes.

Conditions

  • Pregnancy-associated Gingivitis

Interventions

BEHAVIORAL

counseling

The 8-week study includes 3 visits to the dental facility at the Center for Women's Reproductive Health at UAB. Study visits are scheduled to coincide with pre-natal visits in the same facility. Each visit will include individually tailored one-to-one discussion with a dental professional coupled with a demonstration and instructions for using oral hygiene products. Home-care kits will be dispensed, to include a helpful digital video disk (DVD), a high-tech powered toothbrush, dental floss, toothpaste and alcohol-free mouth rinse and subjects will have their teeth professionally cleaned. First and final visits will include collection of gingival crevicular fluid and blood samples and subjects will complete pre and post study questionnaires.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Michael S Reddy, DMD, DMSc · University of Alabama at Birmingham

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00641901 on ClinicalTrials.gov