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

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ClinicalTrials.gov Identifier: NCT02080403
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dexcel Pharma Technologies Ltd.

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.


Condition or disease Intervention/treatment Phase
Peri-Implantitis Drug: 2.5 mg Chlorhexidine gluconate chip Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.
Actual Study Start Date : July 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : November 2018


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 Name: PerioChip®

No Intervention: Control
Mechanical Subgingival Debridement at Baseline and 3 months.



Primary Outcome Measures :
  1. Absolute change in mean probing Pocket Depth for selected target implants [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. Absolute change in mean probing Pocket Depth of selected target implants in patients with baseline Pocket Depth measurement of 6-8 mm inclusive [ Time Frame: Baseline to 6 months ]
  2. Change in percentage of selected target implants Bleeding on Probing [ Time Frame: Baseline to 4 and 6 months ]
  3. Absolute change in mean probing Pocket Depth of selected target implants [ Time Frame: Baseline to 4 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080403


Locations
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United States, Maryland
University of Maryland, School of Dentistry, Department of Periodontics
Baltimore, Maryland, United States
United States, Massachusetts
The Harvard School of Dental Medicine
Boston, Massachusetts, United States, 02115
Tufts University, School of Dental Medicine, Department of Oral Medicine
Boston, Massachusetts, United States
United States, Michigan
University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine
Ann Arbor, Michigan, United States
United States, New York
Columbia University, College of Dental Medicine ,Division of Periodontics
New York, New York, United States, 10032
Stony Brook University, School of Dental Medicine, Department of Periodontology
Stony Brook, New York, United States, 11794-8700
Germany
Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie
Giessen, Germany, 35392
Israel
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, Israel, 9602
The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem
Jerusalem, Israel
United Kingdom
Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)
London, United Kingdom
Sponsors and Collaborators
Dexcel Pharma Technologies Ltd.
Investigators
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Study Chair: Eli Machtei, Prof. Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602
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Responsible Party: Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier: NCT02080403    
Other Study ID Numbers: CLI/016P
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Keywords provided by Dexcel Pharma Technologies Ltd.:
Peri-Implantitis
Periodontal Diseases
Chlorhexidine gluconate
PerioChip
Anti-Infective Agents
Mouth Diseases
Antiseptics
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents