MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk

This study has been completed.

First Received on November 24, 2004. Last Updated on January 3, 2011 History of Changes

Sponsor:	University of North Carolina, Chapel Hill
Collaborator:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	University of North Carolina, Chapel Hill
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 Related Periodontitis Premature Birth	Other: multi-center, randomized, controled periodontal therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: No ]

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

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
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

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Steven Offenbacher, DDS PhD MMS, University of North Carolina
ClinicalTrials.gov Identifier:	NCT00097656 History of Changes
Other Study ID Numbers:	NIDCR-14577, U01DE014577, 5U01DE014577
Study First Received:	November 24, 2004
Last Updated:	January 3, 2011
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Additional relevant MeSH terms:

Periodontitis
Premature Birth
Periodontal Diseases
Mouth Diseases

Stomatognathic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on February 12, 2012