Periodontal Infection and Prematurity Study - Full Text View

Purpose

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment

Official Title:	Periodontal Infection and Prematurity Study

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gestational age between 6 and 20 completed weeks

Exclusion Criteria:

Periodontal treatment during the pregnancy
Antibiotic use within 2 weeks of enrollment
Use of antimicrobial mouthwash within 2 weeks
Multiple gestation
Known mitral valve prolapse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116974

Locations


United States, Pennsylvania
	Hospital of the University of Pennsylvania
	Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators


Principal Investigator:	George A Macones, M.D.	University of Pennsylvania

More Information

Responsible Party:	Washington University in St. Louis ( George A. Macones, M.D., Chair, Department of Obstetrics and Gynecology )
Study ID Numbers:	801404
First Received:	June 30, 2005
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00116974
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Dental scaling

Study placed in the following topic categories:

Mouth Diseases

Periodontal Diseases

Pregnancy Complications

Obstetric Labor, Premature

Obstetric Labor Complications

Stomatognathic Diseases

Premature Birth

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00116974