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MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk
This study is currently recruiting participants.
Verified by National Institute of Dental and Craniofacial Research (NIDCR), July 2008
First Received: November 24, 2004   Last Updated: July 15, 2008   History of Changes
Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00097656
  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
Periodontitis
Premature Birth
Other: multi-center, randomized, controled periodontal therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study
Official Title: MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • Birth at less than 37 weeks gestational age [ Time Frame: 37 weeks gestational age ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: February 2004
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
maternal periodontal therapy
Other: multi-center, randomized, controled periodontal therapy
periodontal therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097656

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill,, North Carolina, United States, 27599-7450
Contact: Steven Offenbacher, DDS PhD MMS     919-962-7081     steve_Offenbacher@Dentistry.UNC.EDU    
Contact: David L. Cochran, DDS, PhD     210-567-3604     cochran@uthscsa.edu    
Principal Investigator: Steven Offenbacher, DDS, PhD,            
Sub-Investigator: Donald J Dudley, MD            
Sub-Investigator: David L Cochran, DDS, PhD            
Sub-Investigator: John Hauth, MD            
Sub-Investigator: Michael S Reddy, DMD, DMS            
Sub-Investigator: Amy P Murtha, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Steven Offenbacher, DDS PhD MMS University of North Carolina
  More Information

No publications provided by National Institute of Dental and Craniofacial Research (NIDCR)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: University of North Carolina ( Steven Offenbacher, DDS PhD MMS )
Study ID Numbers: NIDCR-14577, 5U01DE014577
Study First Received: November 24, 2004
Last Updated: July 15, 2008
ClinicalTrials.gov Identifier: NCT00097656     History of Changes
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 27, 2009