Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-10 @ 8:35 AM
Study NCT ID:
NCT02375750
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2014-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Peri-implantitis Lesions by Using Biomaterial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the dimensions of the bone defect', 'timeFrame': '6 months, 1 year'}], 'secondaryOutcomes': [{'measure': 'Change in pocket depth', 'timeFrame': '3 months,6months, 9 months,12months'}, {'measure': 'Change in gingival inflammation', 'timeFrame': '3 months,6months, 9 months,12months'}, {'measure': 'Changes in recession of the mucosal margin', 'timeFrame': '3 months,6months, 9 months,12months'}, {'measure': 'Subject satisfaction with the outcome at the study end', 'timeFrame': '12months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peri-implantitis']}, 'referencesModule': {'references': [{'pmid': '39020503', 'type': 'DERIVED', 'citation': 'Renvert S, Giovannoli JL, Rinke S. The efficacy of reconstructive therapy in the surgical management of peri-implantitis: A 3-year follow-up of a randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1267-1276. doi: 10.1111/jcpe.14049. Epub 2024 Jul 17.'}, {'pmid': '34169551', 'type': 'DERIVED', 'citation': 'Renvert S, Giovannoli JL, Roos-Jansaker AM, Rinke S. Surgical treatment of peri-implantitis with or without a deproteinized bovine bone mineral and a native bilayer collagen membrane: A randomized clinical trial. J Clin Periodontol. 2021 Oct;48(10):1312-1321. doi: 10.1111/jcpe.13513. Epub 2021 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.', 'detailedDescription': 'Patient who will considered eligible at the screening visit will undergo surgical treatment procedure within 2 weeks. At the day of the surgery the patients will be randomized into the 2 treatment groups.\n\nThe subjects will be then prescribed postoperative antibiotics (Azitromax 500 mg day one and 250 mg day 2-4).\n\nPost-operative pain will be controlled with Ibuprofen (400mg x 3) for two days to all subjects. Subjects will rinse twice daily with Chlorhexidine mouth rinse and use modified oral hygiene procedures during the first 5 weeks of healing. Subjects will receive professional prophylaxis as required.\n\nSubjects will be instructed on appropriate oral hygiene throughout the study and will be given appropriate oral hygiene instructions. Instructions on post-operative care will be repeated at each visit. In particular the following points have to be covered during the first month after surgery: Chlorhexidine rinses, avoidance of brushing, usage of interdental cleaning devices, avoidance of chewing on or trauma to the treated area. In addition subjects will be instructed not to smoke more than 10 cigarettes per day during the entire study period and not to consume alcohol during antibiotic therapy.\n\nSutures will be removed after 14 days. Photos will be taken during the whole study to document the healing process.\n\nFurther follow up visits will be scheduled 6 weeks and 3,6,9,12 months post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* Presence of peri-implantitis\n* A peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.\n* Clinically a probing depth ≥ 5 mm combined with bleeding and/or pus should be present at the site.\n* During surgical exploration an intraosseous component of at least 3 mm at the deepest point must be present.\n* The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included.\n* Implants included in the study must have been in function for more than 12 months.\n* Ability to fully understand the nature of the proposed surgery and ability to sign an Ethics Committee-approved informed consent form\n\nExclusion Criteria:\n\n* Subjects with diabetes mellitus (HbA1c \\> 7.0)\n* Subjects taking prednisone or other anti-inflammatory prescription drug\n* Subjects taking medications known to have effects on gingival growth\n* If the same patient has more than one defect meeting the inclusion criteria, only one such defect will be included in the study\n* General contraindications for dental and/or surgical treatments\n* Smokers (\\> 10 cigarettes per day).\n* Pregnant or lactating women\n* Allergy to collagen\n* Inability to consent for participation in the study and/or to accept the proposed'}, 'identificationModule': {'nctId': 'NCT02375750', 'briefTitle': 'Treatment of Peri-implantitis Lesions by Using Biomaterial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Geistlich Pharma AG'}, 'officialTitle': 'Surgical Treatment of Peri-implantitis Lesions, With or Without the Placement of a Bone Substitute and a Collagen Membrane. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'GS13530231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GBO and GBG', 'description': '0.2 g-0,5 g GBO and 1 GBG once after decontamination of implant surface', 'interventionNames': ['Device: GBO and GBG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Decontamination of surface of implant', 'interventionNames': ['Other: Standard treatment']}], 'interventions': [{'name': 'GBO and GBG', 'type': 'DEVICE', 'description': 'Application of GBO and GBG to the defect fill after removal of chronic inflammatory tissue and decontamination of the surface of implant', 'armGroupLabels': ['GBO and GBG']}, {'name': 'Standard treatment', 'type': 'OTHER', 'description': 'Removal of chronic inflammatory tissue using titanium curettes and a rotary titanium brush; Implant Surface decontamination and closure by suturing', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29188', 'city': 'Kristianstad', 'country': 'Sweden', 'facility': 'Kristianstad University, Department of Health Sciences', 'geoPoint': {'lat': 56.03129, 'lon': 14.15242}}], 'overallOfficials': [{'name': 'Stefan Renvert, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Health Sciences, Kristianstad University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geistlich Pharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}