Long-term Safety of Minocycline in Patients With Gum Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis|
- Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture [ Time Frame: from Baseline to Day 30 and Day 180 ] [ Designated as safety issue: No ]Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
- Micocycline-Resistance From Plaque Samples [ Time Frame: Baseline, Day 30 and Day 180 ] [ Designated as safety issue: No ]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
- Micocycline-Resistance From Saliva Sample [ Time Frame: Baseline, Day 30 and Day 180 ] [ Designated as safety issue: No ]Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects
|Study Start Date:||December 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Minocycline HCl microspheres
Minocycline HCl microspheres
Drug: Minocycline HCl microspheres
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.
Other Name: minocycline
No Intervention: No drug intervention
No drug intervention
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.