The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
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| ClinicalTrials.gov Identifier: NCT02080403 |
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Recruitment Status :
Completed
First Posted : March 6, 2014
Last Update Posted : November 6, 2018
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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 |
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 : | 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 |
|---|---|
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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.
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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® |
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No Intervention: Control
Mechanical Subgingival Debridement at Baseline and 3 months.
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- Absolute change in mean probing Pocket Depth for selected target implants [ Time Frame: Baseline to 6 months ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| 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 | |
| Study Chair: | Eli Machtei, Prof. | Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602 |
| 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 |
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Peri-Implantitis Periodontal Diseases Chlorhexidine gluconate PerioChip |
Anti-Infective Agents Mouth Diseases Antiseptics |
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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 |