This study will look at the safety of using the study medicine for a long time. It will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time.
The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. This will be assessed through monitoring the total number and proportion of minocycline-resistant bacteria and the identity of minocycline-resistant species within a panel of 40 representative periodontal species in saliva and subgingival plaque.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.
Forsyth Institute
Boston, Massachusetts, United States
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
Time frame: from Baseline to Day 30 and Day 180
Micocycline-Resistance From Plaque Samples
Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples
Time frame: Baseline, Day 30 and Day 180
Micocycline-Resistance From Saliva Sample
Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects
Time frame: Baseline, Day 30 and Day 180
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