Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05577520
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2022-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059546', 'term': 'Sinus Floor Augmentation'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016025', 'term': 'Bone Transplantation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Small particle group (SPG n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.\n\nLarge particles group (LPG n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-09', 'studyFirstSubmitDate': '2022-10-09', 'studyFirstSubmitQcDate': '2022-10-09', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of newly formed bone (NB)', 'timeFrame': '10 month', 'description': 'histomorphometric parameter was assessed in a standardized area'}, {'measure': 'Percentage of bone substitute', 'timeFrame': '10 month', 'description': 'histomorphometric parameter was assessed in a standardized area'}, {'measure': 'Percentage of bone marrow', 'timeFrame': '10 month', 'description': 'histomorphometric parameter was assessed in a standardized area'}, {'measure': 'Percentage of osseointegration', 'timeFrame': '10 month', 'description': 'histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sinus floor augmentation', 'Xenograft', 'Anorganic', 'Bovine bone', 'Histomorphometry'], 'conditions': ['Maxillary Sinus Augmentation']}, 'referencesModule': {'references': [{'pmid': '15626319', 'type': 'BACKGROUND', 'citation': 'Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.'}, {'pmid': '1737600', 'type': 'RESULT', 'citation': 'Smiler DG, Johnson PW, Lozada JL, Misch C, Rosenlicht JL, Tatum OH Jr, Wagner JR. Sinus lift grafts and endosseous implants. Treatment of the atrophic posterior maxilla. Dent Clin North Am. 1992 Jan;36(1):151-86; discussion 187-8.'}, {'pmid': '14971260', 'type': 'RESULT', 'citation': 'Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.'}, {'pmid': '18724852', 'type': 'RESULT', 'citation': 'Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.'}, {'pmid': '21906186', 'type': 'RESULT', 'citation': 'Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x.'}, {'pmid': '18828820', 'type': 'RESULT', 'citation': 'Bornstein MM, Chappuis V, von Arx T, Buser D. Performance of dental implants after staged sinus floor elevation procedures: 5-year results of a prospective study in partially edentulous patients. Clin Oral Implants Res. 2008 Oct;19(10):1034-43. doi: 10.1111/j.1600-0501.2008.01573.x.'}, {'pmid': '6993637', 'type': 'RESULT', 'citation': 'Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.'}, {'pmid': '3516738', 'type': 'RESULT', 'citation': 'Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.'}, {'pmid': '12361071', 'type': 'RESULT', 'citation': 'Pejrone G, Lorenzetti M, Mozzati M, Valente G, Schierano GM. Sinus floor augmentation with autogenous iliac bone block grafts: a histological and histomorphometrical report on the two-step surgical technique. Int J Oral Maxillofac Surg. 2002 Aug;31(4):383-8. doi: 10.1054/ijom.2002.0286.'}, {'pmid': '11429944', 'type': 'RESULT', 'citation': 'van den Bergh JP, ten Bruggenkate CM, Krekeler G, Tuinzing DB. Sinusfloor elevation and grafting with autogenous iliac crest bone. Clin Oral Implants Res. 1998 Dec;9(6):429-35. doi: 10.1034/j.1600-0501.1996.090608.x.'}, {'pmid': '21087317', 'type': 'RESULT', 'citation': 'Chackartchi T, Iezzi G, Goldstein M, Klinger A, Soskolne A, Piattelli A, Shapira L. Sinus floor augmentation using large (1-2 mm) or small (0.25-1 mm) bovine bone mineral particles: a prospective, intra-individual controlled clinical, micro-computerized tomography and histomorphometric study. Clin Oral Implants Res. 2011 May;22(5):473-80. doi: 10.1111/j.1600-0501.2010.02032.x. Epub 2010 Nov 19.'}, {'type': 'RESULT', 'citation': 'Pebé PJ, Ramos A, Beovide AV, Borgia G, Ravecca T. Ensayo clínico aleatorizado de elevación sinusal por abordaje lateral con hueso mineral bovino desproteinizado (hmbd) comparando dos tamaños de partículas: resultados clínicos e histológicos. Odontoestomatología. 2017;19:57-67.'}, {'pmid': '30442550', 'type': 'RESULT', 'citation': 'de Molon RS, Magalhaes-Tunes FS, Semedo CV, Furlan RG, de Souza LGL, de Souza Faloni AP, Marcantonio E Jr, Faeda RS. A randomized clinical trial evaluating maxillary sinus augmentation with different particle sizes of demineralized bovine bone mineral: histological and immunohistochemical analysis. Int J Oral Maxillofac Surg. 2019 Jun;48(6):810-823. doi: 10.1016/j.ijom.2018.09.003. Epub 2018 Nov 13.'}, {'pmid': '23820706', 'type': 'RESULT', 'citation': 'Testori T, Wallace SS, Trisi P, Capelli M, Zuffetti F, Del Fabbro M. Effect of xenograft (ABBM) particle size on vital bone formation following maxillary sinus augmentation: a multicenter, randomized, controlled, clinical histomorphometric trial. Int J Periodontics Restorative Dent. 2013 Jul-Aug;33(4):467-75. doi: 10.11607/prd.1423.'}]}, 'descriptionModule': {'briefSummary': 'The decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Objective: To histologically and histomorphometrically compare bone repair response to 250 to 1000 µm and 1000 to 2000 µm anorganic bovine bone mineral (ABBM) particles as bone substitute in maxillary sinus augmentation (MSA).', 'detailedDescription': "Twenty patients were treated with SMA in two steps. They were randomly assigned to one of two groups (n=10): SPG (small particles group) and LPG (large particles group). Different size ABBM particles were implanted in their maxillary sinus, accordingly. A vertical bone core biopsy was obtained at the implant site using a punch trephine. The samples were processed for histological observation and measured histomorphometrically to determine the percentage onewly formed bone (%NB), bone substitute (%BS), bone marrow (%BM), and osseointegration (%OI). Results were statistically analyzed using Student's t test (p ≤ 0.05)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients over the age of 21 years\n* Patients missing teeth in the maxillary sinus region (uni- or bilaterally) with a residual subantral bone height ≤ 4 mm and an alveolar ridge width ≥ 6mm.\n* Patients who had not undergone tooth extraction within 6 months prior to enrollment.\n\nExclusion Criteria:\n\n* Patients with diabetes, blood discrasias, a history of head and neck chemotherapy/radiation therapy, acute sinusitis or a history of allergic sinusitis, chronic polypoid sinusitis, or sinus tumors, or a history of Caldwell-Luc surgery\n* Women who were pregnant or of childbearing age\n* Alcoholics and drug abusers\n* Patients requiring MS treatment showing anatomical features of the MS that contraindicated the surgical treatment\n* Patients who refused to sign the informed consent form\n\nPatients with a history of chronic periodontitis were treated and then enrolled in the study. Patients who developed post-operative maxillary sinus infection or showed allergic reactions attributable to the grafting material were eliminated from the study.'}, 'identificationModule': {'nctId': 'NCT05577520', 'briefTitle': 'Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles', 'organization': {'class': 'OTHER', 'fullName': 'Universidad del Salvador, Argentina'}, 'officialTitle': 'Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles: a Histomorfometric Comparison', 'orgStudyIdInfo': {'id': 'VRDI 1801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Small particle group (SPG)', 'description': 'SPG (n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.', 'interventionNames': ['Procedure: Sinus floor augmentation']}, {'type': 'EXPERIMENTAL', 'label': 'Large particles group (LPG)', 'description': 'LPG (n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.', 'interventionNames': ['Procedure: Sinus floor augmentation']}], 'interventions': [{'name': 'Sinus floor augmentation', 'type': 'PROCEDURE', 'otherNames': ['Sinus floor lift', 'Sinus floor elevation'], 'armGroupLabels': ['Large particles group (LPG)', 'Small particle group (SPG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1125', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'jorge aguilar, Chair Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salvador University /Argentine Dental Association (USAL/AOA)'}, {'name': 'Sandra Renou, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Buenos Aires University (Argentine)'}, {'name': 'Alicia Labandeira, Chair Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salvador University /Argentine Dental Association (USAL/AOA)'}, {'name': 'Maria Piloni, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buenos Aires University (Argentine)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad del Salvador, Argentina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Professor, Oral Implantology Program', 'investigatorFullName': 'Jorge Ernesto Aguilar', 'investigatorAffiliation': 'Universidad del Salvador, Argentina'}}}}