Clinical Trial: Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations

Brief Summary:

The objective of the study is to evaluate the safety, effectiveness and anti-microbial effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.

The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.


Detailed Summary:
Sponsor: OraPharma

Current Primary Outcome: Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 180 ]

Original Primary Outcome: Reduction of Probing Depth [ Time Frame: Baseline and Day 180 ]

The primary efficacy measure is the reduction of probing depth from Baseline to Day 180 of qualifying implant sites.


Current Secondary Outcome:

  • Change in percentage of qualifying implants with Bleeding On Probing [ Time Frame: Baseline to Day 180 ]
  • Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 90 ]
  • Change in percentage of qualifying implants with Bleeding on Probing [ Time Frame: Baseline to Day 90 ]


Original Secondary Outcome:

  • Changes in proportions and numbers of the red-complex bacteria [ Time Frame: Baseline and Day 30 ]
  • Reduction of Bleeding on Probing [ Time Frame: Baseline and Day 180 ]
  • Reduction of Probing Depth and Bleeding on Probing [ Time Frame: Baseline and Day 90 ]


Information By: OraPharma

Dates:
Date Received: January 10, 2012
Date Started: May 2012
Date Completion:
Last Updated: August 25, 2015
Last Verified: April 2014