Long-term Safety of Minocycline in Patients With Gum Disease

Periodontitis Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

• NCT number: NCT00668746
• Study type: Interventional
• Source: OraPharma
• Status: Completed
• Phase: Phase 4
• Start date: December 2007
• Completion date: February 2009