Pregnancy Related Clinical Trial
Official title:
MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk
Verified date | January 2018 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1800 |
Est. completion date | May 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Birth at less than 37 weeks gestational age | 37 weeks gestational age |
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