drugset / Trial / NCT01079663

The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis

NCT01079663 ↗

Phase 2 Completed 60 enrolled Dexcel Pharma Technologies Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.

Timeline

Start
2010-03
Primary completion
2011-10
Completion
2011-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Chlorhexidine Chip (Periochip®) vs Placebo Chip; p = 0.1629; Mean Difference (Final Values) -0.49 (95% CI -1.19 to 0.20); Mixed Models Analysis NCT01079663 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine gluconate Other / unclassified 2.5 mg Other

Indications