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

Phase 3

Completed

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.

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Treatment	2.5 mg Chlorhexidine gluconate chip	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.

Primary Outcome Measures

Name	Time	Method
Absolute Change in Mean Probing Pocket Depth for Selected Target Implants	Baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Percentage of Selected Target Implants Bleeding on Probing (BOP)	6 months	The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant
Precentage of Selected Target Implant BOP	Week 16	The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant

Locations (10): University of Maryland, School of Dentistry, Department of Periodontics
🇺🇸
Baltimore, Maryland, United States
Stony Brook University, School of Dental Medicine, Department of Periodontology
🇺🇸
Stony Brook, New York, United States
Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)
🇬🇧
London, United Kingdom
Columbia University, College of Dental Medicine ,Division of Periodontics
🇺🇸
New York, New York, United States
Tufts University, School of Dental Medicine, Department of Oral Medicine
🇺🇸
Boston, Massachusetts, United States
The Harvard School of Dental Medicine
🇺🇸
Boston, Massachusetts, United States
Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie
🇩🇪
Giessen, Germany
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, Israel
University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine
🇺🇸
Ann Arbor, Michigan, United States