Periodontal Infection and Prematurity Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Periodontal Diseases Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Scaling and root planing

Intervention Type PROCEDURE

Scaling and root planing

2

Group Type PLACEBO_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

Scaling and root planing

Interventions

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Scaling and root planing

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No