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

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
2.5 mg Chlorhexidine gluconate chip
Sponsored by
Dexcel Pharma Technologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-Implantitis, Periodontal Diseases, Chlorhexidine gluconate, PerioChip, Anti-Infective Agents, Mouth Diseases, Antiseptics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Maryland, School of Dentistry, Department of Periodontics
  • The Harvard School of Dental Medicine
  • Tufts University, School of Dental Medicine, Department of Oral Medicine
  • University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine
  • Columbia University, College of Dental Medicine ,Division of Periodontics
  • Stony Brook University, School of Dental Medicine, Department of Periodontology
  • Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie
  • Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
  • The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem
  • Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

Mechanical Subgingival Debridement at Baseline and 3 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Precentage of Selected Target Implant BOP
The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant

Full Information

First Posted
March 4, 2014
Last Updated
August 24, 2022
Sponsor
Dexcel Pharma Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02080403
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexcel Pharma Technologies Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
Peri-Implantitis, Periodontal Diseases, Chlorhexidine gluconate, PerioChip, Anti-Infective Agents, Mouth Diseases, Antiseptics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Mechanical Subgingival Debridement at Baseline and 3 months.
Intervention Type
Drug
Intervention Name(s)
2.5 mg Chlorhexidine gluconate chip
Other Intervention Name(s)
PerioChip®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Absolute Change in Mean Probing Pocket Depth for Selected Target Implants
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive
Description
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.
Time Frame
Baseline to 6 months
Title
Percentage of Selected Target Implants Bleeding on Probing (BOP)
Description
The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant
Time Frame
6 months
Title
Precentage of Selected Target Implant BOP
Description
The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Machtei, Prof.
Organizational Affiliation
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602
Official's Role
Study Chair
Facility Information:
Facility Name
University of Maryland, School of Dentistry, Department of Periodontics
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
The Harvard School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Tufts University, School of Dental Medicine, Department of Oral Medicine
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Columbia University, College of Dental Medicine ,Division of Periodontics
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Stony Brook University, School of Dental Medicine, Department of Periodontology
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8700
Country
United States
Facility Name
Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
City
Haifa
ZIP/Postal Code
9602
Country
Israel
Facility Name
The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem
City
Jerusalem
Country
Israel
Facility Name
Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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