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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date November 6, 2018
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
Absolute change in mean probing Pocket Depth for selected target implants [ Time Frame: Baseline to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • 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 ]
  • Change in percentage of selected target implants Bleeding on Probing [ Time Frame: Baseline to 4 and 6 months ]
  • Absolute change in mean probing Pocket Depth of selected target implants [ Time Frame: Baseline to 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Official Title  ICMJE Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peri-Implantitis
Intervention  ICMJE 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®
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 2.5 mg Chlorhexidine gluconate chip
  • No Intervention: Control
    Mechanical Subgingival Debridement at Baseline and 3 months.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2018)
290
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
250
Actual Study Completion Date  ICMJE November 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Israel,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080403
Other Study ID Numbers  ICMJE CLI/016P
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dexcel Pharma Technologies Ltd.
Study Sponsor  ICMJE Dexcel Pharma Technologies Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eli Machtei, Prof. Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602
PRS Account Dexcel Pharma Technologies Ltd.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP