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

National Institute of Dental and Craniofacial Research (NIDCR)

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):

Offenbacher S, Beck JD, Jared HL, Mauriello SM, Mendoza LC, Couper DJ, Stewart DD, Murtha AP, Cochran DL, Dudley DJ, Reddy MS, Geurs NC, Hauth JC; Maternal Oral Therapy to Reduce Obstetric Risk (MOTOR) Investigators. Effects of periodontal therapy on rate of preterm delivery: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):551-9.

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