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

Completed

• Conditions: Minocycline HCl Microspheres; SRP; Biomarkers
• Interventions: Procedure: Measurement of Biomarkers

• Registration Number: NCT04312542
• Lead Sponsor: University of Minnesota

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

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) 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Study Start: 2020-07-21
• Primary Completion: 2022-08-16
• Study Completion: 2022-08-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Participated in interventional phase of the trial STUDY00004876

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SRP with minocycline HCl microspheres	Measurement of Biomarkers	Participants in this cohort received the intervention of minocycline HCl microspheres, 1 mg in the interventional phase of the trial.
SRP without minocycline HCl microspheres	Measurement of Biomarkers	Participants in this cohort did not have minocycline HCl microspheres, 1 mg administered during the interventional phase of the trial.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States