Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg

Study Overview
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Brief Summary
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The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load. A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned. Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period. Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.

Detailed Description
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A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned. The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. Saliva samples, GCF, and blood serum will be collected at four time points (baseline, 1, 3, and 6 month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed for Interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNF-α). Serum will be analyzed for C-reactive protein (hsCRP), haptoglobin (Hp), hemoglobin A1c (Hgb A1c), IL-1, IL-6, and TNF-α.

Official Title
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Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation

Conditions
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Biomarkers, SRP, Minocycline HCl Microspheres

Intervention / Treatment
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* Drug: minocycline HCl microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female At least 21 years of age ADA Class III-IV Chronic Periodontitis Scaling and Root Planing (SRP) or localized SRP A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant) Exclusion Criteria: Unable to comply with study protocol Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months 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.) Tetracycline allergy Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists, 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRP with minocycline HCl microspheres<br>The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. | Drug: minocycline HCl microspheres<br>* Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.<br>* Other names: Arestin;|
| No Intervention: SRP without minocycline HCl microspheres<br>The control group will not have minocycline HCl microspheres, 1 mg administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pathogenic Burden | Scale 0-100 | baseline, 1, 3, and 6 months |