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

University of Minnesota60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

SRP Minocycline HCl Microspheres Biomarkers

Interventions

Measurement of BiomarkersPROCEDURE

Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Serum Haptoglobin Concentration

Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.

Time frame: 9 months

Serum Haptoglobin Concentration

Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.

Time frame: 12 months

Data from ClinicalTrials.gov

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