Peri-ImplantitisPhase 3NCT02080403
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
A Phase 3 study testing 2.5 mg Chlorhexidine gluconate chip in people with Peri-Implantitis, run by Dexcel Pharma Technologies Ltd. at 10 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- 2.5 mg Chlorhexidine gluconate chip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Jul 2014to Nov 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States6 sites
University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine
Ann Arbor, Michigan
University of Maryland, School of Dentistry, Department of Periodontics
Baltimore, Maryland
The Harvard School of Dental Medicine
Boston, Massachusetts, 02115
Tufts University, School of Dental Medicine, Department of Oral Medicine
Boston, Massachusetts
Columbia University, College of Dental Medicine ,Division of Periodontics
New York, New York, 10032
Stony Brook University, School of Dental Medicine, Department of Periodontology
Stony Brook, New York, 11794-8700
Israel2 sites
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, 9602
The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem
Jerusalem
Germany1 site
Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie
Giessen, 35392
United Kingdom1 site
Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)
London
About this study
Official title: Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.
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.
Read the 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.
- Conditions
- Peri-Implantitis
- Being tested
- 2.5 mg Chlorhexidine gluconate chip
- Keywords
- Peri-Implantitis, Periodontal Diseases, Chlorhexidine gluconate, PerioChip, Anti-Infective Agents, Mouth Diseases, Antiseptics
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5 mg Chlorhexidine gluconate chipDrug
Also called PerioChip®
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Drug: 2.5 mg Chlorhexidine gluconate chip |
| Control | No intervention | Mechanical Subgingival Debridement at Baseline and 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (3)
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.
Measured: Baseline to 6 months
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
Measured: 6 months
Precentage of Selected Target Implant BOP
The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexcel Pharma Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eli Machtei, Prof., Study chair, Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080403
- Sponsor's protocol ID
- CLI/016P
- Status last verified
- Aug 2022
- First submitted
- 4 Mar 2014
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.
- ClinicalTrials.gov ID
- NCT02080403
- Acronym / sponsor ID
- CLI/016P
- Conditions
- Peri-Implantitis
- Keywords
- Peri-Implantitis, Periodontal Diseases, Chlorhexidine gluconate, PerioChip, Anti-Infective Agents, Mouth Diseases, Antiseptics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Dexcel Pharma Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: 2.5 mg Chlorhexidine gluconate chipTreatment, 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. |
| Control | No intervention | –Mechanical Subgingival Debridement at Baseline and 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2.5 mg Chlorhexidine gluconate chipAlso: PerioChip®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. | Drug | Treatment |
Primary outcome
Absolute Change in Mean Probing Pocket Depth for Selected Target Implants
Time frame: Baseline to 6 months
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.
3 secondary outcomes
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
Percentage of Selected Target Implants Bleeding on Probing (BOP)
Time frame: 6 months
Precentage of Selected Target Implant BOP
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli Machtei, Prof. study chair
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2.5 mg Chlorhexidine gluconate chip in people with Peri-Implantitis, run by Dexcel Pharma Technologies Ltd. at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Mean Probing Pocket Depth for Selected Target Implants (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.