Periodontal Infection and Prematurity Study

Periodontal Diseases Clinical Trial

Official title:

Periodontal Infection and Prematurity Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00116974
• Other study ID #: 801404
• Status: Terminated
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: August 12, 2016
• Start date: October 2004
• Est. completion date: February 2009

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2100
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases
• Premature Birth

Intervention

Procedure:
• Scaling and root planing
Scaling and root planing

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks		9 months	No