Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy

Study Overview
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Brief Summary
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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) at 9 and 12 month follow-up post scaling and rootplaning (SRP) with and without minocycline HCl microspheres, 1 mg.

Detailed Description
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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) identifying the effects of SRP with and without minocycline HCl microspheres, 1 mg on periodontal pathogens and systemic inflammatory markers in the blood serum will be invited to participate in this 9 and 12 month follow-up study.

Official Title
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Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1mg

Conditions
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SRP, Minocycline HCl Microspheres, Biomarkers

Intervention / Treatment
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* Procedure: Measurement of Biomarkers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Participated in interventional phase of the trial STUDY00004876 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SRP with minocycline HCl microspheres<br>Participants in this cohort received the intervention of minocycline HCl microspheres, 1 mg in the interventional phase of the trial. | Procedure: Measurement of Biomarkers<br>* Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.<br>|
| SRP without minocycline HCl microspheres<br>Participants in this cohort did not have minocycline HCl microspheres, 1 mg administered during the interventional phase of the trial. | Procedure: Measurement of Biomarkers<br>* Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Hemoglobin A1C Concentration | Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes). | 9 months | 
| Serum Hemoglobin A1C Concentration | Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes). | 12 months | 
| Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration | Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l. | 9 months | 
| Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration | Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l. | 12 months | 
| Serum Haptoglobin Concentration | Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl. | 9 months | 
| Serum Haptoglobin Concentration | Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl. | 12 months |