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Trial record 1 of 336 for:    oral health and pre term birth
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A Study to Evaluate Associations Between Gingivitis and Pregnancy Outcomes (TRIUMPH)

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ClinicalTrials.gov Identifier: NCT00641901
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Reddy, DMD, University of Alabama at Birmingham

Tracking Information
First Submitted Date March 17, 2008
First Posted Date March 24, 2008
Last Update Posted Date March 1, 2013
Study Start Date January 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2008)
Reduced gingival inflammation [ Time Frame: 8 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 17, 2008)
Reduced pre-term birth [ Time Frame: 40 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Evaluate Associations Between Gingivitis and Pregnancy Outcomes
Official Title A Study of Oral Health Care Education and Therapy to Reduce Gingivitis During Pregnancy
Brief 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.

Detailed Description

Adverse pregnancy outcomes are significant personal and public health issues in the United States where approximately 12% of all births are pre-term (<37 weeks gestation). Care for these neonates accounts for over 5 million neonatal intensive care hospital stays each year and close to $6 Billion in annual health care costs. Premature delivery and low birth weight (LBW) are leading determinates of neonatal mortality and serious morbidity often leading to neurological and developmental restrictions in early childhood. Concomitant to these data are significant social and psychological consequences related to maternal and family distress and the effects of personal loss.

The role of maternal periodontitis as a potential stressor having detrimental effects on pregnancy outcomes is a relatively new area of investigation. Nevertheless, increasing evidence exists to support an association between maternal periodontal disease, a chronic anaerobic inflammatory condition of the oral cavity, and adverse pregnancy outcomes including pre-term birth (PTB) and fetal growth restriction. This is particularly true with very early-in-gestation delivery.

After adjusting for age, race, smoking and parity, a prospective study of over one-thousand pregnant women conducted at the University of Alabama at Birmingham (UAB) demonstrated that periodontal disease is associated with an increased risk of pre-term birth (PTB) by an odds ratio 4-7, depending on disease severity. These data showed a 55% prevalence of periodontal disease among this cohort; a much higher prevalence than had been reported in national surveys.

The mechanisms responsible for this association remain unclear. However, substantial data suggest that systemic inflammation, as measured by serum C-reactive protein and other inflammatory mediators may well underlie the observed associations.

Investigators hypothesize that links between maternal infections and pre-term bith involve microbes and host response to microbes that enter the uterine cavity during pregnancy. In cases of remote infection, such as periodontitis, this may occur via a blood-bourne route which triggers an alteration in the normal cytokine and hormone regulatory gestation that can result in premature labor, early rupture of membranes and preterm birth.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

Samples of venous blood and gingivial crevicular fluid (GCF)will be collected at baseline and at week-8.

GCF samples will be harvested from two non-adjacent oral sites, flash-frozen in liquid nitrogen and stored at -70 degrees F. until batched testing. GCF samples will be analyzed for TNFalpha, IL1beta and IL 6 by Lumidex methodology.

Blood samples will be analyzed for Serum Inflammatory markers, C-Reative Protein and inflammatory cytokines.

Sampling Method Non-Probability Sample
Study Population The Center for Women's Reproductive Heath at UAB
Condition Pregnancy-associated Gingivitis
Intervention 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.

Other Names:
  • Pre and Post-study questionnaires
  • Instructional DVD
  • Brushing and flossing instruction
  • Oral examination
  • Oral prophylaxis
Study Groups/Cohorts Observation
Pregnant women with gingivitis
Intervention: Behavioral: counseling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 17, 2008)
120
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Confirmed pregnancy between 16 and 24 weeks gestation
  • Minimum of 20 natural teeth
  • Gingival inflammation 50% of teeth

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00641901
Other Study ID Numbers F070117004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Reddy, DMD, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators Not Provided
Investigators
Principal Investigator: Michael S Reddy, DMD, DMSc University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date February 2013