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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
University of Minnesota
Minneapolis, Minnesota, United States
Bacteria Load (log10)
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).
Time frame: Baseline
Bacteria Load (log10)
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).
Time frame: 3 months
Bacteria Load (log10)
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).
Time frame: 6 months
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