NCT00662532

Antibiotic Study for Dental Implants

Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: OraPharma · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

Detailed description

At Visit 1, the dentist will: * do an oral exam * ask some questions * decide if the person qualifies for being in the study * make an appointment for Visit 2 if they qualify At Visit 2 (Baseline), the dentist will: * do a special cleaning of the implants * examine the whole mouth * collect some fluid * take x-rays * put the people into one of two groups (taking into account whether or not they smoke) 1. one group will have the study antibiotic put on all the areas in their mouth with gum problems 2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected. At Visit 4 (about 3 months later), the dentist will: * collect fluid samples * examine the whole mouth * apply the antibiotic again for people in that group At Visit 5 (about 6 months later), the dentist will: * collect fluid samples * examine the whole mouth * take x-rays

Conditions

• Periodontitis

Interventions

Type	Name	Description
DRUG	Minocycline HCl	1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-04-21
• Last updated: 2011-12-12
• Results posted: 2010-05-27

Locations

4 sites across 1 country: United States