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Obstetrics and Periodontal Therapy (OPT) Study
This study is currently recruiting patients.
Sponsored by: | National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
Purpose
The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).
Condition | Treatment or Intervention | Phase |
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Periodontitis Infant, Premature |
Procedure: Periodontal scaling and root planing |
Phase III |
MedlinePlus related topics: Gum Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effects of Periodontal Therapy on Preterm Birth
Expected Total Enrollment: 816
Study start: March 2003;
Study completion: July 2006
Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. Volunteers will be recruited from Hennepin County Medical Center (MN), the Jackson Medical Mall (MS), the University of Kentucky, and Harlem (NY) Hospital. The incidence of preterm birth is higher at these sites than the national average. Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. All women will also receive essential dental care to restore caries and treat abscessed teeth. The primary birth outcome is gestational age at birth and the secondary outcome is birthweight. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. The study will also document the effect of periodontal therapy on immune reponse, systemic markers of inflammation, periodontal infection and clinical periodontal measure.
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion
Exclusion
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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