Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 7:46 PM
Study NCT ID:
NCT06780956
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2024-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simplified vs Conventional Drilling Protocol for Implant Placment
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal bone loss (MBL)', 'timeFrame': '24 month', 'description': 'Is a non-infective remodeling process of variable entity occurring after implant placement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MBL', 'Bone Loss']}, 'descriptionModule': {'briefSummary': 'Despite the growing interest in these alternative drilling protocols, there is a lack of robust clinical evidence evaluating their long-term effects on MBL. The aim of the present study was therefore, to evaluate the effect of implant site preparation technique (conventional drilling versus simplfied) on change in the marginal bone level and insertion torque.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients without any systemic pathologies that could be considered grounds for absolute contraindication.\n* Adult patients who agreed to participate in the study and signed the informed consent form.\n* Patients who smoked fewer than ten cigarettes per day.\n* Patients who were not completely edentulous.\n* Patients who were partially edentulous in the posterior maxillary or mandibular area and did not require the use of regenerative techniques.\n* Patients with an area of healed, mature bone at least three months post-extraction.\n\nExclusion Criteria:\n\n* Patients missing teeth in the esthetic zones 13-23 and 33-43 (second and fifth sextants).\n* Patients who smoked more than ten cigarettes per day.\n* Patients with a bleeding index greater than 30%.\n* Patients with dental caries or periodontal disease.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT06780956', 'briefTitle': 'Simplified vs Conventional Drilling Protocol for Implant Placment', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Peri-implant Tissue Stability of Simplified vs Conventional Drilling Protocol Randomized Trial With 24-month Follow-up.', 'orgStudyIdInfo': {'id': 'CE092002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional', 'description': 'Conventional Drilling Protocol', 'interventionNames': ['Other: Conventional']}, {'type': 'EXPERIMENTAL', 'label': 'simplfied', 'description': 'simplfied drilling protocol', 'interventionNames': ['Other: simplfied']}], 'interventions': [{'name': 'Conventional', 'type': 'OTHER', 'description': 'conventional drilling protocol using full sequence', 'armGroupLabels': ['conventional']}, {'name': 'simplfied', 'type': 'OTHER', 'description': '3 burrs for implant placment', 'armGroupLabels': ['simplfied']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30100', 'city': 'Murcia', 'country': 'Spain', 'facility': 'UCAM', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Artiom Lijnev', 'investigatorAffiliation': 'San Antonio Technologies - San Antonio Catholic University of Murcia'}}}}