Long-term Safety of Minocycline in Patients With Gum Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Minocycline HCl microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally healthy over 25 years of age moderate-to-severe chronic periodontitis documented informed consent willing to comply with contraceptive requirements free from any significant oral soft tissue pathology Exclusion Criteria: willing to adhere to prohibitions and restrictions of the study oral health inappropriate for study inclusion females self-reporting pregnancy or lactation, or having a positive urine pregnancy result reporting any of the following conditions: allergy to a tetracycline-class drug systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline HCl microspheres<br>Minocycline HCl microspheres | Drug: Minocycline HCl microspheres<br>* 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.<br>* Other names: minocycline;|
| No Intervention: No drug intervention<br>No drug intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture | Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent. | from Baseline to Day 30 and Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline, Day 30 and Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic periodontitis, antibiotic resistance