Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-28 @ 1:18 AM
Study NCT ID:
NCT04789759
Status:
UNKNOWN
Last Update Posted:
2021-03-10
First Post:
2021-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomaterial Clinical Performance in a Socket Preservation Model
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Person who does the volumetric analysis is blinded, Person who makes data treatment is blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Case Series of 10 consecutive cases , with one extraction (at least ) with a type 2 socket, Control group, 10 consecutive dental extractions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-06', 'studyFirstSubmitDate': '2021-02-13', 'studyFirstSubmitQcDate': '2021-03-06', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histologic Examination Histomorphometric Analysis', 'timeFrame': '3 month after tooth extraction', 'description': 'Histologic measure, percentage of Vital Bone formation, Fibrous/connective tissue, and material remnant present in the sample.'}], 'secondaryOutcomes': [{'measure': 'Volumetric Changes Clinical', 'timeFrame': 'at pre-extraction and at final crown insertion up to 1 year', 'description': 'Measure Linear changes reverse engineering software (Geomagic Control X, 3D Systems) in mm.'}, {'measure': 'Radiographic CBCT - Bone evaluation', 'timeFrame': 'at pre-extraction and at final crown insertion up to 1 year', 'description': 'Measure Linear changes in bone from T0 baseline to Implant Placement T1 in mm'}, {'measure': 'Primary and Secondary stability', 'timeFrame': 'at implant placement and at dental crown insertion up to 1 year', 'description': 'Measure the Resonance Frequency Analysis at implants placed in regenerated bone'}, {'measure': 'Incidence of Implant Success rate', 'timeFrame': 'at final treatment (crown insertion) up to 1 year', 'description': 'Measure implant status peri-implant parameters , bleeding on probing in percentage of sites'}, {'measure': 'Implant probing depth', 'timeFrame': 'At implant insertion and At final treatment (crown insertion) up to 1 year', 'description': 'Measure the attachment loss in mm'}, {'measure': 'Implant marginal bone loss.', 'timeFrame': 'at implant placement and at final crown insertion (up to 1 year)', 'description': 'Measure bone position regarding Implant Platform'}, {'measure': 'Incidence of Survival rate', 'timeFrame': 'at dental crown placement (final treatment) up to 1 year', 'description': 'if the implant is osseointegrated'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss', 'Alveolar Bone Resorption']}, 'descriptionModule': {'briefSummary': "When a dental extraction is performed, sequential cascade of events happens that lead to a modeling and remodeling of the area.\n\nThis phenomenon leads to bone resorption and consequential volume loss atrophy. In literature several biomaterials (Autogenous, alloplastic, allografts and xenografts) were tested as alveolar fillers with the aim of controlling this physiologic event.\n\nSocket preservation is today a very widely spread dental technic to preserve the alveolar dimensions, that uses a wide range of biomaterials.\n\nAlloplastic materials have a fair evidence to work in several regenerative procedures in the oral and maxillofacial region.\n\nThis pilot trial aims to characterize Histologic bone healing pattern in a human socket preservation model of 2/3 biphasic calcium sulfate cement matrix's and Hydroxyapatite (HA granules).\n\nAlterations in Volumetric alveolar socket changes in a socket preservation clinical model will also be studied.", 'detailedDescription': "Aim : To evaluate histologic performance and volumetric outcome of a bone substitute used in dentistry for guided bone regeneration procedures.\n\nModel : Human Socket preservation surgery with a control group of spontaneous alveolar healing.\n\nInclusion criteria includes a class 2 or 3 (loss of at least 1/3 of the buccal bone of the alveolar socket) post-extraction sockets.\n\nClinical Experimental Methodology :\n\nAtraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement , fill with 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) and covered with a resorbable membrane.\n\n3 Month after a CBCT is performed for implant planning.\n\nAt implant placement a 2 mm trephine will be used for core extraction.\n\nMeasurements (Stl File) on the day of surgery (Baseline T0) and at implant placement (3 month after tooth extraction) (T1) and after delivery final crown (T2).\n\nDiscrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant will be used at T0, T1 and T2.\n\nHistologic measure comprise percentage of vital bone formation, fibrous/connective tissue, and material remnant, in a socket preservation model\n\nTo Measure Volumetric changes reverse engineering software (Geomagic Control X, 3D Systems) will be used.\n\nOther evaluation parameters involve radiographic Cone Beam Computer Tomography evaluation, primary stability, implant survival and implant success rate\n\nClinical Control Methodology :\n\nAtraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement Measurements (Stl File) on the day of surgery (Baseline T0) and at 3 month after tooth extraction) (T1) Discrepancy (Trueness) Between Standard Tessellation Language Files in Teeth Adjacent to Implant will be used at T0 and T1"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 or over\n2. requiring extraction of teeth in the premolar region and anterior maxilla (15-25), presence of intact 2/3 or less, buccal bone plate\n3. ASA (Physical Status Classification System, American Society of Anesthesiologist) I or II.\n\nExclusion Criteria:\n\n1. patients with uncompensated systemic diseases, metabolic and healing disorders, i.e. diabetes mellitus, hyperparathyroidism, cancer, HIV,\n2. heavy smokers (\\>5 cigarettes/ day),\n3. bone metabolic diseases,\n4. severe renal dysfunction or liver disease,\n5. had received systemic corticosteroids or other immunosuppressive agents, radiation therapy and/or chemotherapy for the past 2 months,\n6. active infections in the surgical site\n7. patients with periodontal or/and endodontic disease'}, 'identificationModule': {'nctId': 'NCT04789759', 'briefTitle': 'Biomaterial Clinical Performance in a Socket Preservation Model', 'organization': {'class': 'NETWORK', 'fullName': 'International Advanced Dentistry, Lisbon'}, 'officialTitle': 'Comparative Clinical Performance of Biphasic Calcium Sulfate Cement Matrix With Hydroxyapatite Granules in a Socket Preservation Model: a Pilot Clinical Trial Parallel Group Assignment', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Socket Preservation Alloplastic Material', 'description': "10 Consecutive Patients with hopeless teeth and 1/3 or more buccal bone resorption will be placed in a therapy go bone regeneration called socket preservation technique.\n\nThe surgery will include placement of 2/3 biphasic calcium sulfate cement matrix's with hydroxyapatite (HA granules) to fill the alveolar defects, and place a resorbable membrane sutured to adjacent tissue, to avoid material leakage.\n\nNo flap retraction. 3 Month later an implant will be placed, and a bone biopsy of the healed socket harvested. 2 Month later a final Zirconia ceramic crown screw retained to the osseointegrated implant.\n\nPrimary (T0) and Secondary (T1) stability measured with ISQ values.\n\nIntraoral Scanner and an STL File will be taken at T0 , T1 and T2 for volumetric alteration evaluation.", 'interventionNames': ['Device: Socket Preservation - Bond Apatite synthetic bone substitute']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extraction Socket Spontaneous Healing', 'description': '10 Consecutive patients with a tooth extraction without the aim of placing a future implant and without Biomaterial filler placed in the socket. Spontaneous healing', 'interventionNames': ['Procedure: Socket healing - No Filler']}], 'interventions': [{'name': 'Socket Preservation - Bond Apatite synthetic bone substitute', 'type': 'DEVICE', 'otherNames': ['alveolar regeneration', 'bone regeneration'], 'description': "Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth. If 1/3 of the buccal plate is missing, considered a class 2 alveolar socket.\n\nExtraction of tooth and place 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) , condensed , and covered with a resorbable membrane suture to the adjacent tissue.\n\nAt implant placement ,take bone for histological preparation and histomorphometric analysis of the healing pattern.\n\nAt T0, T1 and T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing.\n\nVolumetric measurements, will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material.\n\nPrimary and secondary stability will be measured by ISQ units with a RFA machine, that will include the machine to measure and the magnetic tip to be screwed in the implant platform.", 'armGroupLabels': ['Socket Preservation Alloplastic Material']}, {'name': 'Socket healing - No Filler', 'type': 'PROCEDURE', 'otherNames': ['Alveolar Socket spontaneous healing'], 'description': 'Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth, at extraction day, no flap opening , atraumatic extraction, no biomaterial filler, At T0, T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing.\n\nVolumetric measurements will include an intramural scanner from all the stages , we will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material.', 'armGroupLabels': ['Extraction Socket Spontaneous Healing']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andre Chen, Phd', 'role': 'CONTACT', 'email': 'ac@iadlisbon.com', 'phone': '00351919774343'}, {'name': 'Joana Borges', 'role': 'CONTACT', 'email': 'jfb@iadlisbon.com'}], 'overallOfficials': [{'name': 'Andre Chen, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Advanced Dentistry'}, {'name': 'João Borges, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'International Advanced Dentistry'}, {'name': 'Elena Cervino, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'International Advanced Dentistry'}, {'name': 'Amos Yahav, DMD', 'role': 'STUDY_CHAIR', 'affiliation': 'Augma Bio'}, {'name': 'Ofir Yahav, DMD', 'role': 'STUDY_CHAIR', 'affiliation': 'Augma Bio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Advanced Dentistry, Lisbon', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}