Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-28 @ 4:38 AM
Study NCT ID:
NCT06154057
Status:
UNKNOWN
Last Update Posted:
2024-03-12
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Observational Study of Implant-supported Restorations With Dental Implants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).', 'timeFrame': '12 months', 'description': 'The main outcome is the survival rate (%) of successful implant-supported restoration after at least 1-year of occlusal loading (less than 0.5mm of bone loss)'}], 'secondaryOutcomes': [{'measure': 'The survival rate of dental implants produced by additive manufacturing installed in different areas grafted with synthetic bone grafts (Plenum® Osshp)', 'timeFrame': '12 months', 'description': 'Survival rate (%) of successful implant-supported restorations (less than 0.5mm of bone loss) placed in different bone areas (pristine bone, grafted areas with Plenum Oss including maxillary sinus augmentation, guided bone regeneration for both vertical and horizontal augmentation, and extraction sockets).'}, {'measure': 'Rate of bone loss', 'timeFrame': '12 months', 'description': 'A periapical x-ray will be performed at the implant placement region to check the bone level concerning the implant platform. Then, a vertical line will be drawn from the initial line to the bone level for measurement (mm). Standardized intraoral periapical radiographs will be obtained using a dental X-ray machine with a 35 cm long cone. The exposure parameter was 70 kV (Peak), 15mA, and 1/4s at a focus-sensor distance of 30cm. The X-rays will be captured with a digital camera and transferred to a personal computer. Image processing software will be used to store the scanned images. Subsequently, the images will be made available on a monitor and a linear measurement will be performed with software.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Implants', 'Synthetic Bone Graft', 'Additive Manufacture', 'Bone Loss', 'Success Rate'], 'conditions': ['Oral Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). In addition, the biological and biomechanical performance of implant restorations supported through an observational retrospective solution will be observed. From 50 to 100 survey participants will be selected, who will be invited to attend the clinic for clinical, radiographic, and prosthetic evaluation and successful parameters between baseline, 3, 6, and 12 months. The data obtained regarding bone loss (primary outcome) of the analyzed regions and implant success and survival in area grafted with Plenum® Osshp (secondary outcome) will be evaluated by the paired t-test for the evaluation of the times (3, 6, and 12 months) and survival curves of the installed dental implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical parameters:\n\n* Presence or absence of pain or tenderness\n* Presence or absence of suppuration or exudation\n* Presence or absence of mobility\n\nProsthetic parameters\n\n\\- Presence or absence of mechanical complications (problems in prefabricated components such as screws and abutments).\n\nRadiographic Parameters\n\n* Presence or absence of peri-implant radiolucidity.\n* maintenance and quality of the bone graft volume in the grafted area to each clinical indication: ridge augmentation, extraction sites (socket preservation or dental implant preparation/placement) and sinus lifting.\n* Distance between the shoulder of the implant and the first visible bone contact (in mm).\n* Presence or absence of technical complications such as fracture or loss of porcelain structures.\n\nSuccess Parameters\n\n* Absence of pain or tenderness.\n* Absence of suppuration or exudation.\n* Clinical absence of implant mobility.\n* Absence of peri-implant radiolucency.\n* Minor loss of up to 1.5mm in the first year of function.\n* Absence of mechanical or technical complications in the dental implant and in the prosthesis to the dental implants installed in an area grafted.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06154057', 'briefTitle': 'Retrospective Observational Study of Implant-supported Restorations With Dental Implants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'M3 Health'}, 'officialTitle': 'Retrospective Observational Study of Implant-supported Restorations With Implants Produced by Additive Manufacturing', 'orgStudyIdInfo': {'id': 'Plenum Oss 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dental Implants installed in an grafted area (sinus lifting)', 'description': 'Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - sinus lifting.', 'interventionNames': ['Procedure: Dental Implants installed in an grafted area (sinus lifting)']}, {'type': 'EXPERIMENTAL', 'label': 'Dental Implants installed in an grafted area (ridge augmentation)', 'description': 'Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - ridge augmentation.', 'interventionNames': ['Procedure: Dental Implants installed in an grafted area (ridge augmentation)']}, {'type': 'EXPERIMENTAL', 'label': 'Dental Implants installed in an grafted area (extraction sites)', 'description': 'Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - extraction sites (socket preservation or dental implant preparation/placement).', 'interventionNames': ['Procedure: Dental Implants installed in an grafted area (extraction sites)']}], 'interventions': [{'name': 'Dental Implants installed in an grafted area (sinus lifting)', 'type': 'PROCEDURE', 'otherNames': ['maxillary sinus lift'], 'description': 'The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.', 'armGroupLabels': ['Dental Implants installed in an grafted area (sinus lifting)']}, {'name': 'Dental Implants installed in an grafted area (ridge augmentation)', 'type': 'PROCEDURE', 'otherNames': ['Guided bone regeneration'], 'description': 'The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.', 'armGroupLabels': ['Dental Implants installed in an grafted area (ridge augmentation)']}, {'name': 'Dental Implants installed in an grafted area (extraction sites)', 'type': 'PROCEDURE', 'otherNames': ['Guided bone regeneration'], 'description': 'The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.', 'armGroupLabels': ['Dental Implants installed in an grafted area (extraction sites)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guarulhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Guarulhos', 'geoPoint': {'lat': -23.46278, 'lon': -46.53333}}], 'overallOfficials': [{'name': 'Jamil A Shibli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guarulhos, UnG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M3 Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Guarulhos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}