A Study to Evaluate Associations Between Gingivitis and Pregnancy Outcomes
Completed
Conditions studied: Pregnancy-associated Gingivitis
In brief
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.
Key facts
- Study ID
- NCT00641901
- Run by
- University of Alabama at Birmingham
- People needed
- 120
- Starts
- 2007-01-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2013-03-01
Who can join
Age: 16 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Confirmed pregnancy between 16 and 24 weeks gestation
- Minimum of 20 natural teeth
- Gingival inflammation 50% of teeth
You may not qualify if…
- Multiple gestations
- Positive history for HIV infection, AIDS, Diabetes Mellitus
- Rampant untreated caries
- Concomitant Orthodontic treatment
- Medical condition that requires antibiotic prophylaxis prior to dental treatment
- Chronic use of medication that may cause gingival hypertrophy
- Chronic use of steroids
- Any obstetrical contraindication
Where it is running
- The Center for Women's Reproductive Health at UAB — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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