Clinical Trial: The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.
Brief 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.
Detailed Summary:
This is a research study that uses the drug PerioChip® (active ingredient chlorhexidine gluconate) as an experimental treatment for "periimplantitis". This condition is defined an inflammation affecting the tissues (gums and bone) around an already stable implant, resulting in loss of supporting jaw bone. It is caused by many factors but current research links the condition with the presence of bacteria in the mouth which are responsible for periodontitis (gum disease). If left untreated, this can lead to decreased bone support, weakening of the implant and potential lost of the implant.
Nonsurgical treatment (deep cleaning with instruments to remove plaque) and rigorous diligent oral care at home are commonly used to treat both periimplantitis (gum disease around an implant) and periodontitis (gum disease around teeth).
The medication PerioChip® is a small dental chip (its size is smaller than a match head, and it is completely flat). The chip contains chlorhexidine gluconate, an antimicrobial agent which is not an antibiotic. The chip is inserted into the gum sulcus that is present around the tooth or implant and biodegrades naturally within 7 to 10 days while releasing the medication.
The purpose of this study is to determine the efficacy of PerioChip® in addition to a standard deep cleaning treatment regime, as compared to standard deep cleaning alone.in a large patient population, and to collect additional safety data about the treatment.
Sponsor: Dexcel Pharma Technologies Ltd.
Current Primary Outcome: Absolute change in mean probing Pocket Depth for selected target implants [ Time Frame: Baseline to 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Absolute change in mean probing Pocket Depth of selected target implants in patients with baseline Pocket Depth measurement of 6-8 mm inclusive [ Time Frame: Baseline to 6 months ]
- Change in percentage of selected target implants Bleeding on Probing [ Time Frame: Baseline to 4 and 6 months ]
- Absolute change in mean probing Pocket Depth of selected target implants [ Time Frame: Baseline to 4 months ]
Original Secondary Outcome: Same as current
Information By: Dexcel Pharma Technologies Ltd.
Dates:
Date Received: March 4, 2014
Date Started: July 2014
Date Completion: July 2017
Last Updated: September 20, 2016
Last Verified: September 2016
