Status:
COMPLETED
Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy
Lead Sponsor:
University of Minnesota
Conditions:
SRP
Minocycline HCl Microspheres
Eligibility:
All Genders
18+ years
Brief Summary
The primary goal of this study is to determine the amount of three systemic markers of inflammation: 1) Hemoglobin A1c (Hgb A1c, 2) High Sensitivity C-Reactive Protein (hsCRP), and 3) Haptoglobin (Hp)...
Detailed Description
Participants from a randomized controlled clinical trial approved by the University of Minnesota (UMN) Institutional Review Board (IRB) STUDY00004876 and registered on ClinicalTrials.gov (NCT03762915)...
Eligibility Criteria
Inclusion
- \- Participated in interventional phase of the trial STUDY00004876
Exclusion
- Unable to comply with study protocol
- Cigarette use within the last year
- ≥2 weeks of antibiotic use in the past three months or antibiotic use in the last six weeks.
- Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)
- Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular disease (ASVD) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization
- Have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes HbA1c \> 7, HIV, etc.)
- Any medication that may impact periodontal conditions (Phenytoin, calciumantagonists, cyclosporin, warfarin, or NSAIDS)
Key Trial Info
Start Date :
July 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 16 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04312542
Start Date
July 21 2020
End Date
August 16 2022
Last Update
September 23 2022
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455