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

Phase 4

Completed

• Conditions: SRP; Minocycline HCl Microspheres; Biomarkers
• Interventions: Drug: minocycline HCl microspheres

• Registration Number: NCT03762915
• Lead Sponsor: University of Minnesota

Brief Summary

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

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.

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: 2018-11-28
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-04
• Study Start: 2019-05-20
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Results First Submitted: 2023-03-31
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Results First Posted: 2024-03-25
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Male and Female
• At least 18 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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP with minocycline HCl microspheres	minocycline HCl microspheres	The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit.

Primary Outcome Measures

Name	Time	Method
Bacteria Load (log10)	6 months	This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.; For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

Trial Locations

Locations (1)

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