Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT06408467
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2024-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring of 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the result of the participants who were measured aMMP-8', 'timeFrame': '1 month', 'description': 'Measure aMMP-8-level ng/ml'}, {'measure': 'the result of the participants who were measured BOP', 'timeFrame': '1 month', 'description': 'measure bleeding on probing in PISF'}, {'measure': 'the result of the participants who were measured PPD', 'timeFrame': '1 month', 'description': 'measure peri-implant pocket depth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peri-implant treatment', 'aMMP-8', 'non-surgical treatment'], 'conditions': ['Peri-implant Mucositis', 'Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '18724855', 'type': 'RESULT', 'citation': 'Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.'}, {'pmid': '25123773', 'type': 'RESULT', 'citation': 'Figuero E, Graziani F, Sanz I, Herrera D, Sanz M. Management of peri-implant mucositis and peri-implantitis. Periodontol 2000. 2014 Oct;66(1):255-73. doi: 10.1111/prd.12049.'}, {'pmid': '32764436', 'type': 'RESULT', 'citation': 'Lahteenmaki H, Umeizudike KA, Heikkinen AM, Raisanen IT, Rathnayake N, Johannsen G, Tervahartiala T, Nwhator SO, Sorsa T. aMMP-8 Point-of-Care/Chairside Oral Fluid Technology as a Rapid, Non-Invasive Tool for Periodontitis and Peri-Implantitis Screening in a Medical Care Setting. Diagnostics (Basel). 2020 Aug 5;10(8):562. doi: 10.3390/diagnostics10080562.'}, {'pmid': '31817894', 'type': 'RESULT', 'citation': 'Alassy H, Parachuru P, Wolff L. Peri-Implantitis Diagnosis and Prognosis Using Biomarkers in Peri-Implant Crevicular Fluid: A Narrative Review. Diagnostics (Basel). 2019 Dec 7;9(4):214. doi: 10.3390/diagnostics9040214.'}, {'pmid': '41358008', 'type': 'DERIVED', 'citation': 'Lahteenmaki H, Raisanen IT, Tervahartiala T, Parnanen P, Patila T, Sorsa T. Monitoring of Nonsurgical Treatment of Peri-Implantitis Traditional Measurement Methods and aMMP-8 Test Technology: A Pilot Study. Int J Dent. 2025 Nov 27;2025:6681032. doi: 10.1155/ijod/6681032. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the response to non-surgical treatment of peri-implantitis diseases during the maintenance phase. The patients underwent non-surgical implant maintenance treatment, and the success of the treatment was measured again after 30 days using the same criteria and methods.', 'detailedDescription': 'For 40 patients, the aMMP-8 test was performed on the buccal gingival pocket of the implant teeth, gingival bleeding (BOP), implant pocket depth (PPD), and a periapical x-ray to measure radiologic bone level (RBL) were taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* implant patients arriving for a maintenance visit at a dental clinic\n* a diagnosis of peri-implant healthy, peri-implant mucositis, or peri-implantitis by a dentist\n* a written informed consent.\n\nExclusion Criteria\n\n* Smoking\n* age under 25\n* antibiotic treatment within six months\n* the maintenance treatment had been completed within 6 months.'}, 'identificationModule': {'nctId': 'NCT06408467', 'briefTitle': 'Monitoring of Non-Surgical Treatment of Peri-implantitis', 'organization': {'class': 'OTHER', 'fullName': 'Lahanna oy'}, 'officialTitle': 'Monitoring of Non-Surgical Treatment of Peri-implantitis, Traditional Measurement Methods and aMMP-8 Test Technology-Cross Sectional Study', 'orgStudyIdInfo': {'id': 'Lahanna'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The effect and monitoring of maintenance therapy for peri-implantitis', 'interventionNames': ['Other: aMMP-8 diagnostic test']}], 'interventions': [{'name': 'aMMP-8 diagnostic test', 'type': 'OTHER', 'description': '40 patients', 'armGroupLabels': ['The effect and monitoring of maintenance therapy for peri-implantitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'University of Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Timo Sorsa, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Helsinki'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'starting in June 2025 and end of January 2026', 'ipdSharing': 'YES', 'description': 'There is a plan to make IPD and related data dictionaries available after the research', 'accessCriteria': 'information can be shared with an email request to share IPD and other support information. Requests are reviewed with the research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahanna oy', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}