Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 5:38 PM
Study NCT ID:
NCT07427602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2025-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peri-implant marginal bone level', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Comparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs'}], 'secondaryOutcomes': [{'measure': 'Implant and restoration survival', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Percentage of implants and restorations present at follow-up time point'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 year', 'description': 'Patient satisfaction measured on a Visual Analogue Scale. Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied).'}, {'measure': 'Plaque score', 'timeFrame': '1 year', 'description': 'Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)'}, {'measure': 'Gingival score', 'timeFrame': '1 year', 'description': 'Health of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa).'}, {'measure': 'Pocket depth', 'timeFrame': '1 year', 'description': 'Probing depth in the peri-implant sulcus in millimeters measured with a periodontal probe.'}, {'measure': 'Bleeding score', 'timeFrame': '1 year', 'description': 'Bleeding in peri-implant sulcus after probing measured with a Bleeding index from 0 to 3.\n\nMinimum = 0 (no bleeding after probing); Maximum = 3 (abundance amount of bleeding after probing).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate implant placement', 'Maxillary esthetic region', 'Prefabricated provisional'], 'conditions': ['Dental Implants, Single-tooth', 'Immediate Dental Implant Placement', 'Crown']}, 'descriptionModule': {'briefSummary': '* Background\n* There is a growing tendency to place a provisional restoration immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better esthetic outcomes. Provisional restorations can be made either chair-side or in the dental laboratory after implant placement. Nowadays, digital planning makes it possible to fabricate the provisional restoration before implant surgery. The advantage of this technique is that the treatment procedure of placement of the provisional restoration immediately after implant placement is much less time consuming for the patient and due to its machined polished character possibly beneficial for soft tissues.\n* Main research question The aim of this retrospective case series study, with full digital workflow, is to evaluate single tooth implant treatment after immediate implant placement in the maxillary aesthetic region, with respect to registration of possible complications during the time of placement and evaluation of the prefabricated provisional registration and evaluation of clinical and radiographical performance and aesthetic outcome with the definitive restoration after at least 1 year in function.\n* Design (including population, confounders/outcomes) The study design is a retrospective, single-arm observational study for evaluation of 50 patients with a failing tooth in the maxillary aesthetic region, which were treated with an implant-supported provisional and definitive restoration by means of a digital workflow. Outcomes: registration of possible complications during the time of placement and evaluation of the provisional registration and evaluation of clinical and radiographical performance and aesthetic outcome with the definitive restoration.\n* Expected results Satisfying results for patients and professionals (VAS-scores and PES/WES-scores).', 'detailedDescription': 'BACKGROUND\n\n• Introduction and rationale There is a growing tendency to place a provisional restoration immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better esthetic outcomes (El Ghoul \\& Chidiac, 2012). It was shown that good esthetic results can be achieved with immediate provisionalization of single-tooth implants placed immediately after failing tooth removal (Zuiderveld EG, Meijer HJA, Gareb B, Vissink A, Raghoebar GM, 2024; Donker VJJ, Raghoebar GM, Slagter KW, Hentenaar DFM, Vissink A, Meijer HJA, 2024).\n\nPopularity of immediate implant loading is related to evolving society factors, including more demanding patients and a wish for direct treatment (Huynh-Ba, Oates, \\& Williams, 2018). Recent developments in the digital workflow in implant dentistry made treatment planning and fabrication of a provisional restoration before implant placement possible, thus making the treatment more predictable for the clinician and even further shortening the treatment duration. Until date, limited studies have been described investigating immediate provisionalization of single-tooth implants placed immediately after failing tooth removal in the esthetic maxillary zone using a provisional restoration fabricated before implant placement.\n\n• Research question The aim of this retrospective case series study, with full digital workflow, is to evaluate single tooth implant treatment after immediate implant placement in the maxillary aesthetic region, with respect to registration of possible complications during the time of placement and evaluation of the prefabricated provisional registration and evaluation of clinical and radiographical performance and aesthetic outcome with the definitive restoration after at least 1 year in function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient is treated with an immediate implant and an immediate prefabricated provisional restoration; the definitive restoration is at least one year in function', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is 18 years or older;\n\n * The implant region is an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;\n * Patient is treated with an immediate implant and an immediate prefabricated provisional restoration;\n * The definitive restoration is at least one year in function\n\nExclusion Criteria:\n\n* Reference intraoral radiograph not available in the medical record'}, 'identificationModule': {'nctId': 'NCT07427602', 'briefTitle': 'Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals: A Retrospective Case Series Study', 'orgStudyIdInfo': {'id': 'Prefabricated provisionals'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'immediate implant placement with prefabricated provisional', 'description': 'patients with immediate implant placement after removal of failing tooth in the maxillary esthetic region and with immediate placement of a prefabricated provisional restoration.', 'interventionNames': ['Device: dental implant with prefabricated provisional restoration']}], 'interventions': [{'name': 'dental implant with prefabricated provisional restoration', 'type': 'DEVICE', 'description': 'prefabricated provisional restoration', 'armGroupLabels': ['immediate implant placement with prefabricated provisional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700RB', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'contacts': [{'name': 'Henny JA Meijer, Professor doctor', 'role': 'CONTACT', 'email': 'h.j.a.meijer@umcg.nl', 'phone': '+31503616161'}, {'name': 'Meijer', 'role': 'CONTACT', 'email': 'h.j.a.meijer@umcg.nl'}, {'name': 'Henny JA Meijer, Professor doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Henny JA Meijer, Professor doctor', 'role': 'CONTACT', 'email': 'h.j.a.meijer@umcg.nl', 'phone': '+31503616161'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}