Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 2:12 PM
Study NCT ID:
NCT06138392
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Study in Early Loaded Hydrophilic Surface Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'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': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance - survival', 'timeFrame': '10 years', 'description': 'Survival was classified as the continued presence of both the implant and reconstruction in the mouth with no need of replacement and/or repair'}, {'measure': 'Clinical performance - implant success', 'timeFrame': '10 years', 'description': 'Implant success was classified as the absence of persisting subjective discomfort (patient compliance), lack of recurrent peri-implant infection with suppuration (European Federation of Periodontology 2018), absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency at the radiological assessment.'}, {'measure': 'Clinical performance - prosthetic success', 'timeFrame': '10 years', 'description': 'Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.'}, {'measure': 'Clinical performance - complications', 'timeFrame': '10 years', 'description': 'A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.'}, {'measure': 'Clinical performance - peri-implant health', 'timeFrame': '10 years', 'description': 'During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.\n\nPeriodontal pockets (1-20) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).'}, {'measure': 'Clinical performance - peri-implant health', 'timeFrame': '10 years', 'description': 'During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.\n\nPlaque index (1-3) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).'}, {'measure': 'Clinical performance - peri-implant health', 'timeFrame': '10 years', 'description': 'During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.\n\nBleeding on probing (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).'}, {'measure': 'Clinical performance - peri-implant health', 'timeFrame': '10 years', 'description': 'During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.\n\nPus (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).'}, {'measure': 'Clinical performance - peri-implant health', 'timeFrame': '10 years', 'description': 'During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.\n\nKeratinized mucosa (mm) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).'}, {'measure': 'Clinical performance - PIBL, implant-crown fit', 'timeFrame': '10 years', 'description': 'To assess Peri-implant Bone Level (mm), a standardized digital periapical radiograph was taken at the scheduled follow-up visits.\n\nAn independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)'}, {'measure': 'Clinical performance - PIBL, implant-crown fit', 'timeFrame': '10 years', 'description': 'To assess implant-crown fit (misfit yes/no), a standardized digital periapical radiograph was taken at the scheduled follow-up visits.\n\nAn independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)'}, {'measure': 'Clinical performance', 'timeFrame': '10 years', 'description': 'Patient satisfaction with the implant treatment was evaluated using a 10 cm visual analogue scale (VAS). From 0 (The worst) to 10 (The best).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental implant', 'Implant crowns', 'Hydrophilic implant surface', 'Early loading', 'Late implant placement'], 'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'Objective: To assess the clinical outcomes and patient satisfaction of early loaded implants with a hydrophilic, moderately rough surface for partially edentulous patients after a follow-up of 8.5 to 9.5 years.\n\nMaterials and methods: A prospective observational single-centre study involving 15 patients with single, delayed placement and early loaded implants in the posterior area was performed. Clinical and radiographical parameters, including biological and technical complications and patient satisfaction, were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated in an University Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals between the ages of 18 and 75 years (inclusive)\n* Partially edentulous patients with missing teeth in the posterior mandible (positions 34-37 and 44-47) and a healed site at least four weeks after tooth extraction\n* Patients requiring a single dental implant\n* Patients with physical status 1 or 2 according to the American Society of Anesthesiologists Classification System\n* Inadequate native bone quality and quantity to place implants with a diameter of ≥4.0 mm\n* Removable prosthesis or complete dentures in the antagonizing dentition\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients with compromised general health contraindicating surgical intervention\n* Presence of conditions requiring chronic routine prophylactic or prolonged use of antibiotics\n* Heavy smokers (exceeding ten cigarettes/day or equivalent) and chewing tobacco users\n* Pregnancy or childbearing potential with a positive urine pregnancy test\n* Insufficient oral hygiene, untreated periodontitis (any residual pockets \\>4 mm), or persistent intra-oral infection\n* Mucosal diseases such as erosive lichen planus\n* Patients with severe bruxism or clenching habits\n* Unwillingness to participate in the study'}, 'identificationModule': {'nctId': 'NCT06138392', 'briefTitle': 'Long-term Study in Early Loaded Hydrophilic Surface Implants', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Clinical and Radiographic Performance of Early Loaded Dental Implants With a Conditioned Hydrophilic Surface: A Prospective Cohort Study With an 8.5- to 9.5-year Follow-up', 'orgStudyIdInfo': {'id': 'Performance of early loading'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'interventionNames': ['Device: Dental implant (ELEMENT RC INICELL, Thommen Medical)']}], 'interventions': [{'name': 'Dental implant (ELEMENT RC INICELL, Thommen Medical)', 'type': 'DEVICE', 'description': 'Dental implant', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Martin Schimmel, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}