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Obstetrics and Periodontal Therapy (OPT) Study

NCT00066131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 823

Last updated 2015-07-27

No results posted yet for this study

Summary

The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).

Conditions

  • Periodontitis
  • Infant, Premature

Interventions

PROCEDURE

Periodontal scaling and root planing

Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.

PROCEDURE

Scaling and root planing

Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Panos Papapanou, DDS, PhD · Harlem Hospital

  • Anthony DiAngelis, DMD · Hennepin County Medical Center, Minneapolis

  • William Buchanan, DDS · Jackson Medical Mall

  • John Novak, DDS · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2005-12-31
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066131 on ClinicalTrials.gov