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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Mechanical Subgingival Debridement at Baseline and 3 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5 mg Chlorhexidine gluconate chip | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eli Machtei, Prof. | Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, School of Dentistry, Department of Periodontics | Baltimore | Maryland | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Version 7 | Aug 2, 2017 | May 6, 2021 |
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| 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 | 6 months |
| Precentage of Selected Target Implant BOP | The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant | Week 16 |
| The Harvard School of Dental Medicine |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Tufts University, School of Dental Medicine, Department of Oral Medicine | Boston | Massachusetts | United States |
| University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine | Ann Arbor | Michigan | United States |
| Columbia University, College of Dental Medicine ,Division of Periodontics | New York | New York | 10032 | United States |
| Stony Brook University, School of Dental Medicine, Department of Periodontology | Stony Brook | New York | 11794-8700 | United States |
| Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie | Giessen | 35392 | Germany |
| Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center | Haifa | 9602 | Israel |
| The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem | Jerusalem | Israel |
| Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL) | London | United Kingdom |
| FG001 | Control | Mechanical Subgingival Debridement at Baseline and 3 months. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | Control | Mechanical Subgingival Debridement at Baseline and 3 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Treat | Posted | Mean | Standard Deviation | mm | Baseline to 6 months | Target implant | Target implant |
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| Secondary | 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. | Intent to Treat | Posted | Mean | Standard Deviation | mm | Baseline to 6 months | Target implant | Target implant |
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| Secondary | 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 | Intent to Treat | Posted | Count of Units | Target implant | 6 months | Target implant | Target implant |
|
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| Secondary | Precentage of Selected Target Implant BOP | The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant | Posted | Count of Units | Target implant | Week 16 | Target implant | Target implant |
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Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 146 | 4 | 146 | 43 | 146 |
| EG001 | Control | Mechanical Subgingival Debridement at Baseline and 3 months. | 2 | 144 | 3 | 144 | 19 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Forearm fracture | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tooth repair | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Artificial crown procedure | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Implant site swelling | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Department Manager | Dexcel Pharma | 972-4-6364000 | 467 | sigalit.melcer@dexcel.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Version 8 | Aug 29, 2017 | May 6, 2021 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Summary of Protocol Changes | Apr 13, 2021 | May 6, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2018 | May 6, 2021 | SAP_003.pdf |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United Kingdom |
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| Israel |
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| Germany |
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| Target implant |
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| Target implant |
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| Target implant |
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