Periodontal Infection and Prematurity Study

Phase 3

Terminated

• Conditions: Periodontal Diseases; Premature Birth

• Registration Number: NCT00116974
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States