Completed
The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis
What is being tested
Chlorhexidine 2.5 mg
+ Placebo chip
Drug
Who is being recruted
Stomatognathic Diseases+1
+ Mouth Diseases
+ Periodontal Diseases
Over 21 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: March 2010
Summary
Principal SponsorDexcel Pharma Technologies Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2010
Actual date on which the first participant was enrolled.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
Official TitleThe Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis
Principal SponsorDexcel Pharma Technologies Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Stomatognathic DiseasesMouth DiseasesPeriodontal DiseasesPeri-Implantitis
Criteria
6 inclusion criteria required to participate
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.
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13 exclusion criteria prevent from participating
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).
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalPerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm
Group II
PlaceboPlacebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Suspended
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, IsraelOpen Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center in Google MapsSuspended
The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center
Tel Aviv, IsraelCompleted2 Study Centers