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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080403
• Other study ID #: CLI/016P
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: November 2018

Study information

• Verified date: August 2022
• Source: Dexcel Pharma Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dexcel Pharma Technologies Ltd.

Countries where clinical trial is conducted

United States,  Germany,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Precentage of Selected Target Implant BOP	The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant	Week 16