The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis

Summary

The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine gluconate chip) in the treatment of patients with Peri-implantitis. The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival debridement is more effective in the treatment of peri-implantitis when compared to the common method of mechanical subgingival debridement alone. The primary efficacy measure will be the reduction in probing pocket depth at 6 months as measured at sites of qualifying target implant.

Timeline

Start

2014-07

Primary completion

2018-10

Completion

2018-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Treatment vs Control; p = 0.1159; Mean Difference (Final Values) -0.18 (95% CI -0.40 to 0.04); Mixed Models Analysis NCT02080403 ↗

Drugs

Indications