Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-02-11 @ 1:59 AM
Study NCT ID:
NCT03357068
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2017-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}, {'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000143', 'term': 'Acids'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split mouth design - one side of mouth is test group, other side is control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical bone block consolidation', 'timeFrame': '5 months', 'description': 'Absence of fibrous tissue by clinical observation'}, {'measure': 'Computerized tomography images bone block consolidation', 'timeFrame': '5 months', 'description': 'Absence of images compatible to fibrosis in cone beam computerized tomography images'}, {'measure': 'Histological bone block consolidation', 'timeFrame': '5 months', 'description': 'Absence of fibrous tissue between bone block and recipient site in histological images.'}], 'secondaryOutcomes': [{'measure': 'Bone width', 'timeFrame': '5 months', 'description': 'Measurement of bone width in mm on cone beam computerized tomography. Ideal if \\>6 mm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Atrophy', 'Bone Resorption']}, 'referencesModule': {'references': [{'pmid': '24171500', 'type': 'BACKGROUND', 'citation': "Rezende ML, Consolaro A, Sant'Ana AC, Damante CA, Greghi SL, Passanezi E. Demineralization of the contacting surfaces in autologous onlay bone grafts improves bone formation and bone consolidation. J Periodontol. 2014 May;85(5):e121-9. doi: 10.1902/jop.2013.130298. Epub 2013 Oct 30."}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of citric acid demineralization in autogenous bone blocks consolidation. Half of participants will receive citric acid treatment at the bone block and recipient site. Other half will receive no demineralization treatment.', 'detailedDescription': 'Autogenous bone grafts are indicated in areas where there is not enough bone height and/or width for implant installation. Treatment of bone surfaces with citric acid, promote a slight demineralization on surface that mimic natural processes of bone demineralization by osteoclasts. Thus, this treatment could accelerate the process of autogenous bone block consolidation to its recipient site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of atrophic anterior maxilla (width 1.5 to 4 mm)\n* Absence of active periodontal disease.\n* Enough bone width on donor sites (oblique line or ment)\n\nExclusion Criteria:\n\n* Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation\n* Smokers\n* Pregnant women\n* Patients receiving radiotherapy or chemotherapy\n* Patients using bisphosphonates'}, 'identificationModule': {'nctId': 'NCT03357068', 'briefTitle': 'Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans: Qualitative, Quantitative and Immunohistochemical Analysis', 'orgStudyIdInfo': {'id': 'FOBblock'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Autogenous bone block surgery without treatment of bone surfaces.', 'interventionNames': ['Procedure: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Acid', 'description': 'Autogenous bone block surgery with citric acid treatment of bone block and recipient site', 'interventionNames': ['Procedure: Acid']}], 'interventions': [{'name': 'Control', 'type': 'PROCEDURE', 'description': 'Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.', 'armGroupLabels': ['Control']}, {'name': 'Acid', 'type': 'PROCEDURE', 'description': 'Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site', 'armGroupLabels': ['Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17012-901', 'city': 'Bauru', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Bauru School of Dentistry', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Carla Andreotti Damante', 'investigatorAffiliation': 'University of Sao Paulo'}}}}