Working… Menu

Periodontal Infection and Prematurity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116974
Recruitment Status : Terminated (Protocol Expired. Terminated by IRB)
First Posted : July 1, 2005
Last Update Posted : August 15, 2016
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 or disease Intervention/treatment Phase
Periodontal Diseases Premature Birth Procedure: Scaling and root planing Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Periodontal Infection and Prematurity Study
Study Start Date : October 2004
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: 1 Procedure: Scaling and root planing
Scaling and root planing

Placebo Comparator: 2 Procedure: Scaling and root planing
Scaling and root planing

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116974

Layout table for location information
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Layout table for investigator information
Principal Investigator: George A Macones, M.D. University of Pennsylvania
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania Identifier: NCT00116974    
Other Study ID Numbers: 801404
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Keywords provided by University of Pennsylvania:
Dental scaling
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontal Diseases
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Mouth Diseases
Stomatognathic Diseases