Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT04983758
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
20-year Implant Survival in Periodontally Healthy and Compromised Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival rate', 'timeFrame': 'Baseline; 10-year at the 20-year follow-up examination', 'description': 'Change in percentage of dental implants in situ / dental implants placed'}], 'secondaryOutcomes': [{'measure': 'Marginal Bone loss', 'timeFrame': 'Baseline; 10-year at the 20-year follow-up examination', 'description': 'Changes in mm of the peri-implant marginal bone loss'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implant Failed', 'Peri-Implantitis', 'Bone Loss']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to compare the long-term outcomes of sandblasted and acid-etched (SLA) implants in patients previously treated for periodontitis and in periodontally healthy patients (PHP) after a follow-up of at least 20-years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients attending the principle investigator (M.R.), a specialist in periodontology, for dental implant therapy between December 1998 and September 2001 were screened for possible inclusion in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complete edentulism;\n* presence of an implant-supported overdenture;\n* mucosal diseases;\n* alcohol and drug abuse;\n* pregnancy;\n* uncontrolled metabolic disorders;\n* aggressive periodontitis;\n* no interest in participating in the study\n\nExclusion Criteria:\n\n* Everything not as Inclusion Criteria'}, 'identificationModule': {'nctId': 'NCT04983758', 'briefTitle': '20-year Implant Survival in Periodontally Healthy and Compromised Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Long-term (20-year) Implant Survival and Success Rates in Patients Healthy and Compromised Patients', 'orgStudyIdInfo': {'id': '168/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PHP', 'interventionNames': ['Other: Oral Rehabilitation with dental implants']}, {'label': 'Moderate PCP', 'interventionNames': ['Other: Oral Rehabilitation with dental implants']}, {'label': 'Severe PCP', 'interventionNames': ['Other: Oral Rehabilitation with dental implants']}], 'interventions': [{'name': 'Oral Rehabilitation with dental implants', 'type': 'OTHER', 'description': 'Patients have been treated with oral dental implants supporting fixed dental prostheses', 'armGroupLabels': ['Moderate PCP', 'PHP', 'Severe PCP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Roccuzzo', 'role': 'CONTACT'}], 'facility': 'University of Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Mario Roccuzzo', 'role': 'CONTACT', 'email': 'mario.roccuzzo@unito.it', 'phone': '+390117714732'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Mario Roccuzzo', 'investigatorFullName': 'Mario Roccuzzo', 'investigatorAffiliation': 'University of Turin, Italy'}}}}