Chlorhexidine Gluconate Chip in Therapy of Peri-implantitis
Research type
Research Study
Full title
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
IRAS ID
145834
Contact name
Nikolaos Donos
Contact email
Sponsor organisation
Dexcel Pharma Technologies Ltd.
Eudract number
2013-000383-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research 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 peri-implantitis (gum disease around an implant) and periodontitis (gum disease around teeth).
PerioChip® is a known medication approved for use in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of periodontal disease (periodontitis) in adults. The medication 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 7-10 days while releasing the medication.
A recently completed clinical study conducted in a small number of patients with peri-implantitis (gum disease around implants) demonstrated that PerioChip® treatment may effectively reduces the peri-implant pockets and exhibits a high safety profile.
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.
This study will include about 246 individuals in 5 medical centers around the world (UK, Germany, USA and Israel) randomly assigned to receive either deep cleaning alone or deep cleaning plus PerioChip®.
There are 10 visits that take place over 7 months. After an initial examination visit followed within 3 weeks by the start of treatment which takes place every 2 weeks over 12 weeks, further follow-up occurs at 16 and 24 weeks after the baseline visit.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/2215
Date of REC Opinion
12 Jan 2015
REC opinion
Further Information Favourable Opinion