Periodontal Infection and Prematurity Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by University of Pennsylvania. Recruitment status was Active, not recruiting

First Received on June 30, 2005. Last Updated on November 30, 2007 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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
Experimental: 1	Procedure: Scaling and root planing Scaling and root planing
Placebo Comparator: 2	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

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jeffcoat M, Parry S, Sammel M, Clothier B, Catlin A, Macones G. Periodontal infection and preterm birth: successful periodontal therapy reduces the risk of preterm birth. BJOG. 2011 Jan;118(2):250-6. Epub 2010 Sep 14.

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

Keywords provided by University of Pennsylvania:

Dental scaling

Additional relevant MeSH terms:

Periodontal Diseases
Premature Birth
Mouth Diseases
Stomatognathic Diseases

Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on February 12, 2012