MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00097656
First received: November 24, 2004
Last updated: January 3, 2011
Last verified: January 2011
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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):
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
Mouth Diseases
Obstetric Labor Complications
Obstetric Labor, Premature
Periodontal Diseases
Pregnancy Complications
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014