Antibiotic Study for Dental Implants

Periodontitis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

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

Related Conditions & MeSH terms

• Peri-Implantitis
• Periodontitis

• NCT number: NCT00662532
• Study type: Interventional
• Source: OraPharma
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Completion date: April 2009