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The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.
This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine chip (Periochip®) | Experimental | PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm |
|
| Placebo chip | Placebo Comparator | Placebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine 2.5 mg | Drug |
| ||
| Placebo chip |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | Pocket depth is the measurement of the distance from the coronal edge of the gingival margin to the base of the pocket. Measurements were taken with a standard 15-mm University of North Carolina (UNC) periodontal probe. Change from baseline in PPD was calculated as Week 24 PPD minus Baseline PPD such that a negative difference indicates an improvement in condition | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Levels (CAL) | Loss of attachment is defined as the distance in millimetres that the base of the pocket has migrated apically from the gingival margin of the crown. CAL was calculated at the same site that PPD was measured | Baseline to Week 24 |
| Bleeding on Probing (BOP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center | Haifa | Israel | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine Chip (Periochip®) | PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg |
| FG001 | Placebo Chip | Placebo chip |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine Chip (Periochip®) | PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg |
| BG001 | Placebo Chip | Placebo chip |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | Pocket depth is the measurement of the distance from the coronal edge of the gingival margin to the base of the pocket. Measurements were taken with a standard 15-mm University of North Carolina (UNC) periodontal probe. Change from baseline in PPD was calculated as Week 24 PPD minus Baseline PPD such that a negative difference indicates an improvement in condition | Posted | Mean | Standard Deviation | mm | Baseline to Week 24 | Target implant | Target implant |
|
Baseline through Week 24
All patients who receive study drug and have at least one follow-up assessment after beginning treatment
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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 | Chlorhexidine Chip (Periochip®) | PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous ulcer | Gastrointestinal 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 |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| 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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|
BOP was measured at the same site after measuring the PPD. The scoring system used for recording the BOP was a dichotomous one: 0 = No bleeding 1 = Bleeding on probing of the pocket base |
| Baseline to Week 24 |
| The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center |
| Tel Aviv |
| Israel |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 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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| Secondary | Clinical Attachment Levels (CAL) | Loss of attachment is defined as the distance in millimetres that the base of the pocket has migrated apically from the gingival margin of the crown. CAL was calculated at the same site that PPD was measured | Posted | Mean | Standard Deviation | mm | Baseline to Week 24 | Target implant | Target implant |
|
|
|
|
| Secondary | Bleeding on Probing (BOP) | BOP was measured at the same site after measuring the PPD. The scoring system used for recording the BOP was a dichotomous one: 0 = No bleeding 1 = Bleeding on probing of the pocket base | Posted | Count of Units | Target implant | Baseline to Week 24 | Target implant | Target implant |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 15 |
| 30 |
| EG001 | Placebo Chip | Placebo chip | 0 | 30 | 2 | 30 | 16 | 30 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Periodontal inflammation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Implant site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Dental restoration failure | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
|
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