Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT05499533
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2022-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000848', 'term': 'Anodontia'}, {'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010027', 'term': 'Osteotomy'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Once selected, patients will be assigned to one of two treatment groups. (test group- hybrid funnel technique; control group- conventional drill technique) Patients are placed in one of the two treatment groups according to the chronological order in which they will be recruited. Age, sex, surgical implant site (upper, lower, anterior, posterior) and clinical l characteristics will be taken into account to obtain two homogeneous study groups.\n\nFirst Hybrid Funnel Technique will be performed, then Conventional drill Technique will be performed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal bone loss', 'timeFrame': '6 months after implant placement', 'description': 'Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost'}, {'measure': 'Marginal bone loss', 'timeFrame': '12 months after implant placement', 'description': 'Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost'}, {'measure': 'Implant stability', 'timeFrame': 'immediately after implant placement', 'description': 'check implant stability using resonant frequency analysis (RFA)'}, {'measure': 'Implant stability', 'timeFrame': '2 months after implant placement', 'description': 'check implant stability using resonant frequency analysis (RFA)'}, {'measure': 'Insertion torque curve', 'timeFrame': 'During implant placement (T0 baseline)', 'description': 'The Insertion torque data were recorded and exported as a curve The torque curve records the amount of energy that was needed for arrive at the positioning of the implantunit of measurement of torque is Newton centimeter (Ncm)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteotomy', 'dental implant', 'marginal bone loss', 'implant stability', 'osteotome', 'implant site preparation'], 'conditions': ['Missing Teeth', 'Edentulous Alveolar Ridge', 'Tooth Loss']}, 'referencesModule': {'references': [{'pmid': '31878016', 'type': 'BACKGROUND', 'citation': 'Yeo IL. Modifications of Dental Implant Surfaces at the Micro- and Nano-Level for Enhanced Osseointegration. Materials (Basel). 2019 Dec 23;13(1):89. doi: 10.3390/ma13010089.'}, {'pmid': '26584202', 'type': 'BACKGROUND', 'citation': 'Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.'}, {'pmid': '29140373', 'type': 'BACKGROUND', 'citation': 'Toia M, Stocchero M, Cecchinato F, Corra E, Jimbo R, Cecchinato D. Clinical Considerations of Adapted Drilling Protocol by Bone Quality Perception. Int J Oral Maxillofac Implants. 2017 Nov/Dec;32(6):1288-1295. doi: 10.11607/jomi.5881.'}, {'pmid': '21682844', 'type': 'BACKGROUND', 'citation': 'Stacchi C, Vercellotti T, Torelli L, Furlan F, Di Lenarda R. Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial. Clin Implant Dent Relat Res. 2013 Apr;15(2):188-97. doi: 10.1111/j.1708-8208.2011.00341.x. Epub 2011 Apr 19.'}, {'pmid': '34208849', 'type': 'BACKGROUND', 'citation': 'Ivanova V, Chenchev I, Zlatev S, Mijiritsky E. Correlation between Primary, Secondary Stability, Bone Density, Percentage of Vital Bone Formation and Implant Size. Int J Environ Res Public Health. 2021 Jun 30;18(13):6994. doi: 10.3390/ijerph18136994.'}, {'pmid': '29537128', 'type': 'BACKGROUND', 'citation': 'Alifarag AM, Lopez CD, Neiva RF, Tovar N, Witek L, Coelho PG. Atemporal osseointegration: Early biomechanical stability through osseodensification. J Orthop Res. 2018 Sep;36(9):2516-2523. doi: 10.1002/jor.23893. Epub 2018 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'Hybrid Funnel Technique arises from the union of subtractive and non-subtractive techniques for implant site preparation. Hybrid funnel technique is performed with specially designed drills and osteotome. the aim of the study is to examine marginal bone level and implant stability of implants inserted with two different techniques for the surgical implant site preparation.', 'detailedDescription': 'Overtime several osteotomy techniques were described in literature for surgical implant site preparation and there is a clear dichotomy between expansive and ablative techniques.\n\nThe ablative techniques imply the preparation of the implant socket by removing bone: drill osteotomy and ultrasonic osteotomy. Expansive technique for osteotomy has recently been proposed: the osseodensification. Osseodensification, a non-subtractive instrumentation method, involves the use of specific drills or manual osteotomes which determine an expansion of the implant site without bone removal and bone fragments compaction on the walls of implant socket.The aim of the present study is to propose a new approach for the implant site preparation that combines ablative and expansive techniques. The technique proposed is called hybrid funnel techniqueAlthough a variety of techniques are available for implant site preparation, the hypothesis is that Hybrid Funnel technique will be positively adopted to perform osteotomy, exploiting the cancellous bone elastic properties to stabilize the implant and avoiding to stress the cortical area. Primary objectives are to compare hybrid funnel technique and traditional technique on different bone densities and to examine Marginal Bone Level torque insertion value and Implant stability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient needing for post-extraction implant supported restoration in the mandibular or maxillary area\n2. ASA 1 E ASA 2\n3. Subject is 30-85 years old\n4. Patients with healthy periodontal conditions (Treated periodontitis, PI\\<25%, BoP\\<25%)\n5. Patients that are willing to sign an informed consent and participate in a clinical study\n\nExclusion Criteria:\n\n1. Absence Type 1-2 post extraction sites\n2. Patient ASA 3 or 4\n3. Any sites where an implant already failed sites\n4. Untreated Periodontitis\n5. Allergy declared to one or more medicaments to be used during treatment\n6. Pregnancy (confirmed by verbal inquiry)'}, 'identificationModule': {'nctId': 'NCT05499533', 'briefTitle': 'Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation', 'organization': {'class': 'OTHER', 'fullName': 'Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo'}, 'officialTitle': 'Hybrid Funnel Technique vs Conventional Drill Osteotomy, a Novel Approach for Implant Site Preparation', 'orgStudyIdInfo': {'id': 'ABT3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid Funnel Technique', 'description': 'Hybrid funnel technique for implant site preparation', 'interventionNames': ['Procedure: implant site preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Technique', 'description': 'Conventional subtractive Drill technique for implant site preparation', 'interventionNames': ['Procedure: implant site preparation']}], 'interventions': [{'name': 'implant site preparation', 'type': 'PROCEDURE', 'otherNames': ['osteotomy'], 'description': 'a hole were created in the edentulous ridge area before implant placement', 'armGroupLabels': ['Conventional Technique', 'Hybrid Funnel Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00198', 'city': 'Rome', 'state': 'Italy/Rome', 'country': 'Italy', 'facility': 'Studio Odont.Associato Dr.P.Cicchese E L.Canullo', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luigi Canullo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Luigi Canullo', 'investigatorAffiliation': 'Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo'}}}}