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

This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis

Inclusion criteria

• Signed and dated Informed Consent Form.
• Good general health.
• Male or female patients aged >21 years old.
• Availability for the 25 week duration of the study.
• Peri-implantitis is characterized by the presence of at least 1 implant with periodontal pockets of 6-10 mm in depth (potential target implant) demonstrating Bleeding on Probing without involving the apex of the implant and confirmed radiographically.
• Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.

Exclusion criteria

• Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
• Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
• Presence of soft or hard tissue tumours of the oral cavity.
• Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
• Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).
• History of allergy to Chlorhexidine.
• Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
• Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration (excluding treatment of acetylsalicylic acid ≤100 mg /day).
• Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
• Presence of any of the following conditions: Type 1 diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
• The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
• Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
• Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.