Expired Study
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Boston, Massachusetts 02115


Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT00668746


Primary Contact:

Study Director
Michael Lynch, DMD, PhD
OraPharma


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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