Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:30 AM
Study NCT ID:
NCT07374757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediately Loaded Implants With or Without Horizontal Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant Success Rate', 'timeFrame': '12 months after implant placement', 'description': 'Implant success is defined as implant survival at 12 months, absence of clinical mobility, absence of persistent pain or infection, absence of peri-implant radiolucency, and no need for implant removal or surgical re-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inmediate loading', 'horizontal bone regeneration'], 'conditions': ['Bone Augmentation Associated With Immediate Loading']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the clinical success and patient-reported outcomes of immediately loaded dental implants placed in sites with buccal dehiscence treated by horizontal augmentation versus immediately loaded implants placed without regeneration techniques.', 'detailedDescription': 'This is a prospective, interventional, non-randomized, comparative clinical trial designed to evaluate the clinical outcomes of immediately loaded dental implants using two different surgical approaches. One group will receive implants placed in sites with buccal dehiscence treated by horizontal bone augmentation, while the comparison group will receive immediately loaded implants placed without the use of any bone regeneration techniques.\n\nThe primary outcome of the study is implant success at 12 months after implant placement. Secondary outcomes include marginal bone level changes, complication rates, and oral health-related quality of life assessed using a validated questionnaire. The study is conducted with a parallel assignment model and an open-label design due to the nature of the surgical interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients requiring dental implant placement Presence of buccal dehiscence at the implant site Indication for immediate loading Ability to provide written informed consent\n\nExclusion Criteria:\n\nUncontrolled systemic diseases Active periodontal disease Heavy smoking exceeding predefined limits Conditions contraindicating oral surgery'}, 'identificationModule': {'nctId': 'NCT07374757', 'acronym': 'ILHA', 'briefTitle': 'Immediately Loaded Implants With or Without Horizontal Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Clinical Outcomes of Immediately Loaded Implants With Buccal Dehiscence Treated by Horizontal Augmentation Compared With Immediately Loaded Implants Without Regeneration Techniques', 'orgStudyIdInfo': {'id': 'UCM2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Horizontal bone augmentation associate with immediate loading', 'description': 'Horizontal bone augmentation associate with immediate loading', 'interventionNames': ['Procedure: guided bone regeneration technique']}, {'type': 'OTHER', 'label': 'Inmediate Loading without bone regeneration technique', 'description': 'Immediately loaded dental implants placed without the use of any bone regeneration or augmentation techniques.', 'interventionNames': ['Procedure: No intervention']}], 'interventions': [{'name': 'guided bone regeneration technique', 'type': 'PROCEDURE', 'description': 'Immediately loaded dental implants placed in sites presenting buccal dehiscence treated by horizontal bone augmentation using a guided bone regeneration technique according to a standardized surgical protocol.', 'armGroupLabels': ['Horizontal bone augmentation associate with immediate loading']}, {'name': 'No intervention', 'type': 'PROCEDURE', 'description': 'Immediately loaded dental implants placed without the use of any bone regeneration or augmentation techniques.', 'armGroupLabels': ['Inmediate Loading without bone regeneration technique']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}