Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02080403
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2014-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sigalit.melcer@dexcel.com', 'phone': '972-4-6364000', 'title': 'Clinical Trial Department Manager', 'phoneExt': '467', 'organization': 'Dexcel Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Screening through Week 24', 'description': 'All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', '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.\n\n2.5 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.', 'otherNumAtRisk': 146, 'deathsNumAtRisk': 146, 'otherNumAffected': 43, 'seriousNumAtRisk': 146, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 19, 'seriousNumAtRisk': 144, 'deathsNumAffected': 2, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Implant site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Post procedural discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tooth repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Artificial crown procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Implant site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change in Mean Probing Pocket Depth for Selected Target Implants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Target implant', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', '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.\n\n2.5 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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.69', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1159', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.04', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', '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.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target implant', 'denomUnitsSelected': 'Target implant', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Target implant', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', '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.\n\n2.5 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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.77', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', '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.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target implant', 'denomUnitsSelected': 'Target implant', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Selected Target Implants Bleeding on Probing (BOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Target implant', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', '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.\n\n2.5 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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 months', 'description': 'The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant', 'unitOfMeasure': 'Target implant', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target implant', 'denomUnitsSelected': 'Target implant', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Precentage of Selected Target Implant BOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Target implant', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', '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.\n\n2.5 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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Week 16', 'description': 'The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant', 'unitOfMeasure': 'Target implant', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target implant', 'denomUnitsSelected': 'Target implant'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', '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.\n\n2.5 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.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', '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.\n\n2.5 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.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-02', 'size': 987620, 'label': 'Study Protocol: Version 7', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-06T11:09', 'hasProtocol': True}, {'date': '2017-08-29', 'size': 1005256, 'label': 'Study Protocol: Version 8', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-06T11:10', 'hasProtocol': True}, {'date': '2021-04-13', 'size': 593602, 'label': 'Study Protocol: Summary of Protocol Changes', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-06T11:11', 'hasProtocol': True}, {'date': '2018-08-15', 'size': 812953, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-06T11:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2014-03-04', 'resultsFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-22', 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change in Mean Probing Pocket Depth for Selected Target Implants', 'timeFrame': 'Baseline to 6 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive', 'timeFrame': 'Baseline to 6 months', '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.'}, {'measure': 'Percentage of Selected Target Implants Bleeding on Probing (BOP)', 'timeFrame': '6 months', 'description': 'The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant'}, {'measure': 'Precentage of Selected Target Implant BOP', 'timeFrame': 'Week 16', 'description': 'The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peri-Implantitis', 'Periodontal Diseases', 'Chlorhexidine gluconate', 'PerioChip', 'Anti-Infective Agents', 'Mouth Diseases', 'Antiseptics'], 'conditions': ['Peri-Implantitis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nNonsurgical 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).\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good general health\n* 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.\n* The implants have been in function for more than 2 years.\n* Fixed prosthetic restoration of the implant.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.\n* Allergic reaction to Chlorhexidine.\n* Active Periodontitis which required definitive treatment.\n* Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.\n* Use of systemic antibiotic therapy and/or chronically use of non-steroidal anti-inflammatory drugs (NSAIDs).\n* Uncontrolled diabetes, of any type.'}, 'identificationModule': {'nctId': 'NCT02080403', 'briefTitle': 'The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dexcel Pharma Technologies Ltd.'}, 'officialTitle': 'Multi-Center Phase 3 Trial of Chlorhexidine Gluconate Chip for the Use in Subjects With Peri-Implantitis.', 'orgStudyIdInfo': {'id': 'CLI/016P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', '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.', 'interventionNames': ['Drug: 2.5 mg Chlorhexidine gluconate chip']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Mechanical Subgingival Debridement at Baseline and 3 months.'}], 'interventions': [{'name': '2.5 mg Chlorhexidine gluconate chip', 'type': 'DRUG', 'otherNames': ['PerioChip®'], '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.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, School of Dentistry, Department of Periodontics', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'The Harvard School of Dental Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University, School of Dental Medicine, Department of Oral Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University, College of Dental Medicine ,Division of Periodontics', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794-8700', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University, School of Dental Medicine, Department of Periodontology', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Zentrum für Zahn,- Mund- und Kieferheilkunde Poliklinik für Parodontologie', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '9602', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'The Faculty of Dental Medicine, Department of Periodontics, Hadassah Ein Karem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London (QMUL)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Eli Machtei, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center Haifa, Israel, 9602'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dexcel Pharma Technologies Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}