The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis

Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.

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.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Drug: 2.5 mg Chlorhexidine gluconate chip

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Giessen, Germany, 35392
    • Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie
• Israel
  • Haifa, Israel, 9602
    • Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
  • Jerusalem, Israel
    • The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem
• United Kingdom
  • London, United Kingdom
    • Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)
• United States
  • Maryland
    • Baltimore, Maryland, United States
      • University of Maryland, School of Dentistry, Department of Periodontics
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • The Harvard School of Dental Medicine
    • Boston, Massachusetts, United States
      • Tufts University, School of Dental Medicine, Department of Oral Medicine
  • Michigan
    • Ann Arbor, Michigan, United States
      • University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine
  • New York
    • New York, New York, United States, 10032
      • Columbia University, College of Dental Medicine ,Division of Periodontics
    • Stony Brook, New York, United States, 11794-8700
      • Stony Brook University, School of Dental Medicine, Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good general health
• At least one implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Including bone loss in combination with bleeding and/or suppuration on probing and a peri-implant Probing Depth (PD) of 5-8 mm.
• The implants have been in function for more than 2 years.
• Fixed prosthetic restoration of the implant.

Exclusion Criteria:

• Pregnancy.
• Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.
• Allergic reaction to Chlorhexidine.
• Active Periodontitis which required definitive treatment.
• Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
• Use of systemic antibiotic therapy and/or chronically use of non-steroidal anti-inflammatory drugs (NSAIDs).
• Uncontrolled diabetes, of any type.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment, 2.5 mg Chlorhexidine Gluconate chip (PerioChip®) inserted every two weeks starting at Baseline for the first 3 months, plus mechanical Subgingival Debridement at Baseline and 3 months.	Drug: 2.5 mg Chlorhexidine gluconate chip; Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant.; Other Names: PerioChip®
No Intervention: Control; Mechanical Subgingival Debridement at Baseline and 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Mean Probing Pocket Depth for Selected Target Implants	Pocket depth was measured as the distance from the coronal edge of the gingival margin to the base of the pocket. It was assessed at 4 sites per implant: mesiobuccal, midbuccal, distobuccal, and midlingual. Only one of the 4 sites, usually the deepest, was determine to be target implant.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive	Pocket depth was measured as the distance from the coronal edge of the gingival margin to the base of the pocket. It was assessed at 4 sites per implant: mesiobuccal, midbuccal, distobuccal, and midlingual. Only one of the 4 sites, usually the deepest, was determine to be target implant.	Baseline to 6 months
Percentage of Selected Target Implants Bleeding on Probing (BOP)	The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant	6 months
Precentage of Selected Target Implant BOP	The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant	Week 16

Collaborators and Investigators

• Sponsor: Dexcel Pharma Technologies Ltd.
• Investigators: Study Chair: Eli Machtei, Prof., Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Anti-Infective Agents; Peri-Implantitis; Chlorhexidine gluconate; Antiseptics; Periodontal Diseases; PerioChip; Mouth Diseases
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: CLI/016P