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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

June 30, 2005
August 12, 2016
October 2004
February 2009   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00116974 on ClinicalTrials.gov Archive Site
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Periodontal Infection and Prematurity Study
Periodontal Infection and Prematurity Study
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Periodontal Diseases
  • Premature Birth
Procedure: Scaling and root planing
Scaling and root planing
  • Experimental: 1
    Intervention: Procedure: Scaling and root planing
  • Placebo Comparator: 2
    Intervention: Procedure: Scaling and root planing
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. doi: 10.1111/j.1471-0528.2010.02713.x. Epub 2010 Sep 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2100
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116974
801404
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University of Pennsylvania
University of Pennsylvania
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Principal Investigator: George A Macones, M.D. University of Pennsylvania
University of Pennsylvania
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP