Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-04 @ 7:45 AM
Study NCT ID:
NCT03841656
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Gum Disease Treatment on Long-term Dental Implant Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-12', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of peri-implantitis as measured by probing depth', 'timeFrame': 'At least 3 years after dental implant placement', 'description': 'The implant has a probing depth more than or equal to 4 mm'}, {'measure': 'Presence of peri-implantitis as measured by erythema', 'timeFrame': 'At least 3 years after dental implant placement', 'description': 'The implant has bleeding on probing'}, {'measure': 'Presence of peri-implantitis as measured by radiographic bone loss', 'timeFrame': 'At least 3 years after dental implant placement', 'description': 'The implant has a radiographic bone loss when compared to previous radiographs'}], 'secondaryOutcomes': [{'measure': 'Implant survival', 'timeFrame': 'At least 3 years after dental implant placement', 'description': 'presence of implant on arch Peri-implant mucositis: presence of bleeding on probing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'referencesModule': {'references': [{'pmid': '35178092', 'type': 'DERIVED', 'citation': 'Papalou I, Vagia P, Cakir A, Tenenbaum H, Huck O, Davideau JL. Influence of Periodontitis, Implant, and Prosthesis Characteristics on the Peri-Implant Status: A Cross-Sectional Study. Int J Dent. 2022 Feb 7;2022:9984871. doi: 10.1155/2022/9984871. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. Investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. The second purpose of this study is to evaluate the influence of other local, systemic, behavioral, and implant's related risk factors"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient attending supporting periodontal therapy with at least one implant placed for more than 3 years\n\n* Patient with more than 12 teeth at baseline\n* Patient with demographic, periodontal, implant data recording\n* patient aged \\>30 years at Baseline\n\nExclusion criteria:\n\n* Patient needed antibiotic prophylaxis\n* Uncontrolled diabetes\n* Systemic inflammatory or autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT03841656', 'briefTitle': 'Influence of Gum Disease Treatment on Long-term Dental Implant Success', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Influence of Periodontal Care Response on Implant Treatment Outcomes at Long-term', 'orgStudyIdInfo': {'id': '67RC001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PARORISKIMPLANT', 'type': 'PROCEDURE', 'description': 'Patients attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Olivier HUCK', 'role': 'CONTACT', 'email': 'olivier.huck@chru-strasbourg.fr', 'phone': '00333', 'phoneExt': '116947'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}