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MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk

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ClinicalTrials.gov Identifier: NCT00097656
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : January 4, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Related Periodontitis Premature Birth Other: multi-center, randomized, controled periodontal therapy Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk
Study Start Date : February 2004
Primary Completion Date : March 2010
Study Completion Date : May 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: Periodontal Treatment
maternal periodontal therapy
Other: multi-center, randomized, controled periodontal therapy
periodontal therapy
Other Name: Periodontal Therapy

Outcome Measures

Primary Outcome Measures :
  1. Birth at less than 37 weeks gestational age [ Time Frame: 37 weeks gestational age ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097656

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)
Principal Investigator: Steven Offenbacher, DDS PhD MMS University of North Carolina
More Information

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 ( U.S. NIH Grant/Contract )
5U01DE014577 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: January 2011

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