Periodontal Infection and Prematurity Study

Phase 3TerminatedNCT00116974

University of Pennsylvania2,100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

2,100

Conditions

Periodontal Diseases Premature Birth

Interventions

Scaling and root planingPROCEDURE

Scaling and root planing

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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