Clinical trial NCT02080403: The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Official title: Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peri-Implantitis
Keywords: Peri-Implantitis
Periodontal Diseases
Chlorhexidine gluconate
PerioChip
Anti-Infective Agents
Mouth Diseases
Antiseptics
Lead sponsor: Dexcel Pharma Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Change in Mean Probing Pocket Depth for Selected Target Implants
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive
timeFrame: Baseline to 6 months
measure: Percentage of Selected Target Implants Bleeding on Probing (BOP)
timeFrame: 6 months
measure: Precentage of Selected Target Implant BOP
timeFrame: Week 16
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, School of Dentistry, Department of Periodontics
state: Maryland
city: Boston
country: United States
facility: The Harvard School of Dental Medicine
state: Massachusetts
city: Boston
country: United States
facility: Tufts University, School of Dental Medicine, Department of Oral Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine
state: Michigan
city: New York
country: United States
facility: Columbia University, College of Dental Medicine ,Division of Periodontics
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University, School of Dental Medicine, Department of Periodontology
state: New York
city: Giessen
country: Germany
facility: Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie
city: Haifa
country: Israel
facility: Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
city: Jerusalem
country: Israel
facility: The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem
city: London
country: United Kingdom
facility: Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)
Study officials:
affiliation: Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602
name: Eli Machtei, Prof.
role: STUDY_CHAIR
References: