Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 10:08 AM
Study NCT ID:
NCT04800406
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2021-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Ten completely edentulous patients aged from 50-60 years'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-13', 'studyFirstSubmitDate': '2021-03-13', 'studyFirstSubmitQcDate': '2021-03-13', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal Bone height changes', 'timeFrame': 'one year', 'description': 'The marginal bone changes around each type of dental implant were assessed by cone beam computed tomography.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implant surface treatment', 'Marginal bone height', 'Cone beam computed tomography'], 'conditions': ['Assess Marginal Bone Height Changes Around Dental Implants']}, 'descriptionModule': {'briefSummary': 'Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Free from any systemic diseases affecting the bone metabolism.\n* Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration.\n* Residual alveolar ridge with adequate height and width.\n* Angel's class I classification maxillo - mandibular relationship.\n* Sufficient inter arch space\n\nExclusion Criteria:\n\n* Smoker.\n* Patients with parafunction habits (clenching or bruxism)."}, 'identificationModule': {'nctId': 'NCT04800406', 'briefTitle': 'Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.', 'organization': {'class': 'OTHER', 'fullName': 'National Research Centre, Egypt'}, 'officialTitle': 'Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.', 'orgStudyIdInfo': {'id': '16007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dental Implants', 'type': 'PROCEDURE', 'description': 'Resorbable blast media surface treated dental implant and Acid etched surface treated dental implant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12622', 'city': 'Cairo', 'state': 'Dokki', 'country': 'Egypt', 'facility': 'National Research Centre', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Asmaa Nabil Elboraey', 'investigatorAffiliation': 'National Research Centre, Egypt'}}}}