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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.
ClinicalTrials.gov Identifier: NCT00116974
Recruitment Status : Terminated (Protocol Expired. Terminated by IRB)
First Posted : July 1, 2005
Last Update Posted : August 15, 2016
Sponsor:
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

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
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00116974     History of Changes
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:
Periodontal Diseases
Gingival Diseases
Premature Birth
Mouth Diseases
Stomatognathic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications