Status:
COMPLETED
MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Pregnancy Related
Periodontitis
Eligibility:
FEMALE
16+ years
Phase:
NA
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 materna...
Detailed Description
STUDY DESIGN: The intervention is designed as a multi-center, randomized, controlled, clinical trial to determine the effects of periodontal therapy on the rate of preterm birth. Study participants w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT00097656
Start Date
February 1 2004
End Date
May 1 2010
Last Update
January 29 2018
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7450