MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk - Full Text View

MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk

This study is currently recruiting participants.
Verified by National Institute of Dental and Craniofacial Research (NIDCR), May 2007

Sponsored by:	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	Procedure: Periodontal Therapy (tooth cleaning)	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, 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

Estimated Enrollment:	1800
Study Start Date:	February 2004
Estimated Study Completion Date:	May 2007

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

Study ID Numbers:	NIDCR-14577, 5U01DE014577
First Received:	November 24, 2004
Last Updated:	May 24, 2007
ClinicalTrials.gov Identifier:	NCT00097656
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Mouth Diseases

Periodontal Diseases

Periodontitis

Obstetric Labor, Premature

Obstetric Labor Complications

Premature Birth

Additional relevant MeSH terms:

Pregnancy Complications

Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 03, 2008