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

Biomarkers Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03762915
Study type Interventional
Source University of Minnesota
Contact
Status Completed
Phase Phase 4
Start date May 20, 2019
Completion date April 1, 2022
View Details
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