Effects of Periodontal Therapy on Preterm Birth

As PI of the University of Kentucky (UKY) clinical enrollment site and Host Response Laboratory for the Obstetrics and Periodontal Treatment (OPT) Study, Dr. M. John Novak will have administrative, scientific and fiscal responsibility for all study-related tasks and activities at UKY. He will be responsible for communicating with the Administrative and Data Coordinating Centers (DCC) on a regular basis and for meeting annually with the Steering Committee. He will supervise all study personnel at UKY. He will be responsible for ensuring that study-related activities are coordinated with those of the obstetrics department and prenatal clinics. Drs. Novak and JefFerguson will serve on the project's Steering Committee. Investigators and staff at the UKY are required to perform all study-related procedures and tasks in strict accordance with the project's Manual of Operations (MOP). They will be responsible for continuing to follow and treat subjects enrolled during year 01, and enroll, treat and follow 12 new subjects per month in year 02 (for a total of 144 new subjects), again in strict accordance with the MOP Required tasks and procedures during year 02 include but are not limited to the following. . Ensure that the clinical examiners remain trained, calibrated and blinded . Recruit and screen potential study subjects from affiliated obstetrics clinics . Identify additional recruitment sites in the event that the number of potential and eligible subjects at existing sites is inadequate to meet enrollment milestones . Obtain informed consent from all subjects in accordance with guidelines established by the local IRB. . Ensure that all subjects meet the enrollment criteria . Inform the Data Coordinating Center of all serious and other adverse events in accordance with study procedures . Collect detailed periodontal data from all subjects at baseline (13-16 weeks of gestation), and at 21-24 weeks and 29-32 weeks of pregnancy . Complete essential dental care on all study subjects as specified in the study MOP . Submit accurate and complete data forms to the Data Coordinating Center at regular and timely intervals in accordance with the study protocol. Except in rare circumstances, all study related forms will be forwarded to the DCC within 10 business days of completion. . Provide prophylactic treatment and oral hygiene instructions to test subjects at monthly intervals . Perform brief oral exams on control subjects at monthly visits . Abstract pertinent medical and obstetrical information from subjects' medical records . For subjects randomized into the test group, provide non-surgical periodontal therapy before 20 weeks of pregnancy . Maintain strict study blinds . Collect whole blood samples and subgingival dental plaque samples from all subjects at baseline and at 29-32 weeks of pregnancy (Visit 5) . Process and ship serum samples to the University of Kentucky in accordance with the study MOP. . Process and ship dental plaque samples to the University of Minnesota in accordance with the study MOP. . Provide non-surgical periodontal therapy to control subjects within three months after delivery. . Refer subjects for follow-up dental care at the completion of the study. . Collect and archive serum samples received the four clinical enrollment sites. . Quantify levels of inflammatory mediators, acute phase proteins and antibodies in the processed serum samples as described in the grant application and MOP. . Transmit validated and accurate serological data to the Dce in a timely manner.