Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2026-01-13 @ 5:11 AM
Study NCT ID:
NCT07288606
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysising the Marginal Bone Loss, Torque and Implant Stability Placed in Bone and Tissue Level Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-01', 'size': 1061924, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-26T08:50', 'hasProtocol': True}, {'date': '2022-07-01', 'size': 697683, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-14T04:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placement of dental implants in bone level and tissue level'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Torque', 'timeFrame': 'up to 24 weeks', 'description': 'N·cm'}, {'measure': 'marginal bone loss', 'timeFrame': '6 months', 'description': 'mm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone level', 'tissue level', 'osseointegration', 'biomechanical analysis', 'implant design', 'Insertion torque'], 'conditions': ['Dental Implant', 'Implant Stability']}, 'descriptionModule': {'briefSummary': 'It is a prospective clinical study to compare two implants of the same brand of a similar design for implantation \\[either at the bone tissue level or at the soft tissue level\\], in order to evaluate the marginal bone loss of each dental implant in mm. 96 patients will be analyzed (an expected N of 48 per group, hoping to reach 100 implants per arm).', 'detailedDescription': 'it is a study to evualte the marginal bone loss in bone level and tissue level dental implants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes, over 18 years of age, who need dental implant placement for prosthetic rehabilitation. Whether partially or completely in both the maxilla and the mandible.\n* Patients with residual alveolar ridge with at least 8 mm of bone height and 4 mm of width.\n* Patients must have the ability to understand and decide when voluntarily signing the informed consent before carrying out any intervention related to the study.\n* Patients who, after being informed about the objectives and procedures of the research, agree will sign the informed consent form. And they are ready to carry out the different study visits.\n\nExclusion Criteria:\n\n* Patients with uncontrolled systemic diseases (ASA ≥ III).\n* Patients who do not have 8mm bone height and/or 4mm width\n* Patients who require bone regeneration\n* Patients with severe periodontal disease or acute pericoronitis.\n* Pregnant and breastfeeding women.\n* Patients with Deficient or Inadequate Oral Hygiene.\n* Patients with severe bruxism.\n* Patients taking bisphosphonates or other antiresority medications.\n* Smoker of more than 10 cigarettes/day.\n* Patients with uncontrolled diabetes mellitus.\n* Psychiatric illnesses or unrealistic expectations.\n* Immunodepressed or immunocompromised patient.'}, 'identificationModule': {'nctId': 'NCT07288606', 'briefTitle': 'Analysising the Marginal Bone Loss, Torque and Implant Stability Placed in Bone and Tissue Level Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'University of Barcelona'}, 'officialTitle': 'Marginal Bone Loss in Implants Placed in Bone Level and Tissue Level', 'orgStudyIdInfo': {'id': '2022-033-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone Level', 'description': 'Placement of a bone-level dental implant. The implant-abutment interface is at the level of the alveolar bone crest.', 'interventionNames': ['Procedure: Dental implant placed in bone level and tissue level']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tissue Level', 'description': 'Placement of a tissue-level dental implant. The implant-abutment interface is located supracrestally, at the level of the soft tissue.', 'interventionNames': ['Procedure: Dental implant placed in bone level and tissue level']}], 'interventions': [{'name': 'Dental implant placed in bone level and tissue level', 'type': 'PROCEDURE', 'otherNames': ['Marginal bone loss'], 'description': 'Evaluate the marginal bone loss, ISQ and torque', 'armGroupLabels': ['Bone Level', 'Tissue Level']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89070', 'city': 'Barcelona', 'state': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': 'Hospital Odontologic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'JOSE L LOPEZ, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'José López Lopez', 'investigatorAffiliation': 'University of Barcelona'}}}}