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

NCT02080403 | Completed Phase 3 Results

• 1 other identifier: CLI/016P
• Study Type: interventional
• Target: 290
• Locations: 4 countries
• Sites: 10

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.

Conditions

Peri-Implantitis

Keywords

Peri-Implantitis; Periodontal Diseases; Chlorhexidine gluconate; PerioChip; Anti-Infective Agents; Mouth Diseases; Antiseptics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive

  Baseline to 6 months

• Percentage of Selected Target Implants Bleeding on Probing (BOP)

  6 months

• Precentage of Selected Target Implant BOP

  Week 16

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

Mechanical Subgingival Debridement at Baseline and 3 months.

Interventions

2.5 mg Chlorhexidine gluconate chip DRUG

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.

Also known as: PerioChip®

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dexcel Pharma Technologies Ltd.: lead

Study Sites (10)

University of Maryland, School of Dentistry, Department of Periodontics

Baltimore, Maryland, United States

Location

The Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location

Tufts University, School of Dental Medicine, Department of Oral Medicine

Boston, Massachusetts, United States

Location

University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine

Ann Arbor, Michigan, United States

Location

Columbia University, College of Dental Medicine ,Division of Periodontics

New York, New York, 10032, United States

Location

Stony Brook University, School of Dental Medicine, Department of Periodontology

Stony Brook, New York, 11794-8700, United States

Location

Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie

Giessen, 35392, Germany

Location

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center

Haifa, 9602, Israel

Location

The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem

Jerusalem, Israel

Location

Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)

London, United Kingdom

Location

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Diseases; Mouth Diseases

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Clinical Trial Department Manager
• Organization: Dexcel Pharma

sigalit.melcer@dexcel.com

972-4-6364000

Study Officials

• Eli Machtei, Prof.

  Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 13, 2022
• Results First Posted: June 23, 2021

Record last verified: 2022-08

Locations

US (6); GB (1); IL (2); DE (1)