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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00116974 |
This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.
Condition | Intervention | Phase |
---|---|---|
Periodontal Diseases Premature Birth |
Procedure: Scaling and root planing |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | Periodontal Infection and Prematurity Study |
Estimated Enrollment: | 2100 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Procedure: Scaling and root planing
Scaling and root planing
|
2: Placebo Comparator |
Procedure: Scaling and root planing
Scaling and root planing
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | George A Macones, M.D. | University of Pennsylvania |
Responsible Party: | Washington University in St. Louis ( George A. Macones, M.D., Chair, Department of Obstetrics and Gynecology ) |
Study ID Numbers: | 801404 |
Study First Received: | June 30, 2005 |
Last Updated: | November 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00116974 |
Health Authority: | United States: Institutional Review Board |
Dental scaling |
Mouth Diseases Periodontal Diseases Pregnancy Complications Obstetric Labor, Premature |
Obstetric Labor Complications Stomatognathic Diseases Premature Birth |