Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05883202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2023-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-05-20', 'studyFirstSubmitQcDate': '2023-05-20', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Soft-tissue volume', 'timeFrame': '1 year', 'description': 'Three-dimensional volume of the soft tissue around the implants'}], 'primaryOutcomes': [{'measure': 'Marginal bone level', 'timeFrame': '1 year', 'description': 'Peri-implant marginal bone level measured by standardized periapical radiography'}], 'secondaryOutcomes': [{'measure': 'Peri-implant microbiome', 'timeFrame': '1 year', 'description': 'Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods'}, {'measure': 'Peri-implant inflammation', 'timeFrame': '1 year', 'description': 'Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jaw, Edentulous, Partially']}, 'referencesModule': {'references': [{'pmid': '24621670', 'type': 'BACKGROUND', 'citation': 'Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, Suarez F, OValle F, Spinato S, Catena A. Prosthetic Abutment Height is a Key Factor in Peri-implant Marginal Bone Loss. J Dent Res. 2014 Jul;93(7 Suppl):80S-85S. doi: 10.1177/0022034513519800. Epub 2014 Mar 12.'}, {'pmid': '32865627', 'type': 'BACKGROUND', 'citation': 'Couso-Queiruga E, Tattan M, Ahmad U, Barwacz C, Gonzalez-Martin O, Avila-Ortiz G. Assessment of gingival thickness using digital file superimposition versus direct clinical measurements. Clin Oral Investig. 2021 Apr;25(4):2353-2361. doi: 10.1007/s00784-020-03558-0. Epub 2020 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied.\n\nTherefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.\n* Possibility of placing a transgingival abutment at least 2 mm high.\n\nExclusion criteria:\n\n* Need for simultaneous bone augmentation.\n* Heavy smokers (\\>10 cigarettes/day).\n* Uncontrolled type 1 or 2 diabetes (HgA1c\\>8).\n* Known autoimmune or inflammatory disease.\n* Serious blood disorders, such as hemophilia or leukemia.\n* Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).\n* Liver or kidney dysfunction/failure.\n* Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.\n* Long-term history of oral bisphosphonates use (i.e., 10 years or more).\n* History of intravenous bisphosphonates.\n* Long-term (\\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.\n* Severe osseous diseases (e.g., Paget disease of bone).\n* Pregnant women or nursing mothers.\n* Not able or not willing to follow instructions related to the study procedures.'}, 'identificationModule': {'nctId': 'NCT05883202', 'briefTitle': 'Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants', 'orgStudyIdInfo': {'id': '2622CEIH2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Connect®', 'description': 'Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.', 'interventionNames': ['Device: Connect®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-unit', 'description': 'Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.', 'interventionNames': ['Device: Multi-unit']}], 'interventions': [{'name': 'Connect®', 'type': 'DEVICE', 'description': 'Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.', 'armGroupLabels': ['Connect®']}, {'name': 'Multi-unit', 'type': 'DEVICE', 'description': 'Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.', 'armGroupLabels': ['Multi-unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'country': 'Spain', 'facility': 'Universidad de Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Miguel Padial-Molina', 'investigatorAffiliation': 'Universidad de Granada'}}}}