Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT05683405
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2023-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'A periodontist that is not involved in the treatment and who is blinded to the treatment received will evaluate the treatment results.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each participant will be randomized to non-surgical treatment of peri-implantitits with either mechanical debridement or with air-polishing.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': '26 weeks', 'description': 'Probing depth 5 millimeters or more'}, {'measure': 'Bleeding on probing', 'timeFrame': '26 weeks', 'description': 'Bleeding from pocket on pocket depth probing'}, {'measure': 'Suppuration on probing', 'timeFrame': '26 weeks', 'description': 'Suppuration from pocket on pocket depth probing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-implantitis', 'Non-surgical treatment', 'Air-polishing', 'Mechanical debridement', 'Bleeding on probing', 'periodontal pocket depth'], 'conditions': ['Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is:\n\n• Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments?\n\nParticipants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise.\n\nResearchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis\n* Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting.\n\nExclusion Criteria:\n\n* Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.'}, 'identificationModule': {'nctId': 'NCT05683405', 'briefTitle': 'Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.', 'organization': {'class': 'OTHER', 'fullName': 'Tannhelsetjenestens Kompetansesenter for Nord-Norge'}, 'officialTitle': 'Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis: Mechanical Debridement vs. Air-polishing', 'orgStudyIdInfo': {'id': '343997'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical debridement', 'interventionNames': ['Procedure: Non-surgical treatment of peri-implantitis with mechanical debridement']}, {'type': 'EXPERIMENTAL', 'label': 'Air polishing', 'interventionNames': ['Procedure: Non-surgical treatment of peri-implantitis with air polishing']}], 'interventions': [{'name': 'Non-surgical treatment of peri-implantitis with mechanical debridement', 'type': 'PROCEDURE', 'description': 'Non-surgical treatment of peri-implantitis with mechanical debridement .', 'armGroupLabels': ['Mechanical debridement']}, {'name': 'Non-surgical treatment of peri-implantitis with air polishing', 'type': 'PROCEDURE', 'description': 'Non-surgical treatment of peri-implantitis with air polishing', 'armGroupLabels': ['Air polishing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9271', 'city': 'Tromsø', 'state': 'Troms', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Elin Hadler-Olsen', 'role': 'CONTACT', 'email': 'elin.hadlerolsen@tffk.no', 'phone': '+4748067249'}], 'facility': 'Tannhelsetjenestens kompetansesenter for Nord-Norge', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'centralContacts': [{'name': 'Elin Hadler-Olsen, PhD', 'role': 'CONTACT', 'email': 'elin.hadlerolsen@tffk.no', 'phone': '+47 48 06 72 49'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tannhelsetjenestens Kompetansesenter for Nord-Norge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malmö University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}