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
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00116974
First received: June 30, 2005
Last updated: November 30, 2007
Last verified: November 2007
  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 3

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Periodontitis
Mouth Diseases
Stomatognathic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 19, 2014