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MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097656
First Posted: November 25, 2004
Last Update Posted: January 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of North Carolina, Chapel Hill
  Purpose
The purpose of this study is to determine whether maternal periodontal therapy (tooth cleaning) decreases the rate of preterm deliveries at <37 weeks gestation and to determine the effects of maternal periodontal therapy on the birth weight of infants born less than 37 weeks gestation.

Condition Intervention Phase
Pregnancy Related Periodontitis Premature Birth Other: multi-center, randomized, controled periodontal therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Birth at less than 37 weeks gestational age [ Time Frame: 37 weeks gestational age ]

Enrollment: 1800
Study Start Date: February 2004
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Periodontal Treatment
maternal periodontal therapy
Other: multi-center, randomized, controled periodontal therapy
periodontal therapy
Other Name: Periodontal Therapy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing to be randomized and complete treatment protocols and provide informed consent
  • Planning on prenatal care and delivery at the enrollment center
  • Pregnant and able to complete periodontal treatment prior to 236 weeks gestation
  • At least 16 years old at enrollment
  • Minimum of 20 teeth present
  • Three (3) or more periodontal sites with > 3mm clinical attachment loss

Exclusion Criteria:

  • Multiple gestation
  • Positive history of HIV infection, AIDS, autoimmune disease, or diabetes (gestational diabetes is acceptable)
  • Any medical contraindication to periodontal probing or periodontal treatment that would require antibiotic prophylaxis, (e.g., congenital heart disease, use of Phen- fen for weight loss without a clear
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097656


Locations
United States, North Carolina
University of North Carolina
Chapel Hill,, North Carolina, United States, 27599-7450
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Steven Offenbacher, DDS PhD MMS University of North Carolina
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Offenbacher, DDS PhD MMS, University of North Carolina
ClinicalTrials.gov Identifier: NCT00097656     History of Changes
Other Study ID Numbers: NIDCR-14577
U01DE014577 ( U.S. NIH Grant/Contract )
5U01DE014577 ( U.S. NIH Grant/Contract )
First Submitted: November 24, 2004
First Posted: November 25, 2004
Last Update Posted: January 4, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Periodontitis
Premature Birth
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications