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Periodontal Infection and Prematurity Study

This study has been terminated.
(Protocol Expired. Terminated by IRB)
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00116974
First received: June 30, 2005
Last updated: August 12, 2016
Last verified: August 2016
  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

Resource links provided by NLM:


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
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   Child, Adult, Senior
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

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 
Study First Received: June 30, 2005
Last Updated: August 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Dental scaling

Additional relevant MeSH terms:
Premature Birth
Periodontal Diseases
Gingival Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 27, 2016