Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05352620
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2022-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000099066', 'term': 'Atrophic Maxilla'}, {'id': 'D007575', 'term': 'Jaw, Edentulous'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008439', 'term': 'Maxillary Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-23', 'studyFirstSubmitDate': '2022-04-23', 'studyFirstSubmitQcDate': '2022-04-23', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in peri-implant probing depth', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months', 'description': 'The peri-implant sulcus depth will be measured using a graduated plastic periodontal probe.'}, {'measure': 'Change in Clinical Attachment level', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months', 'description': 'It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters'}, {'measure': 'Change in Implant Stability', 'timeFrame': 'at baseline and 9 months', 'description': 'The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ)'}, {'measure': 'Change in alveolar bone level', 'timeFrame': 'at baseline and 9 months', 'description': 'The level of alveolar bone around each abutment will be evaluated using CBCT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrophic Maxilla', 'Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT Equator attachment and inclined implants with smart box attachment radiographically using CBCT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with comparable age (30- 65 years).\n* All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region.\n* Opposing mandibular dentate arch including bilateral posterior teeth.\n* All patients should have an adequate zone of keratinized mucosa.\n* All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants.\n* All patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants.\n\nExclusion Criteria:\n\n* Patients with flabby maxillary ridges.\n* Patients who are unwilling to accept implant overdentures as a treatment modality.\n* Patients with temporomandibular and neuromuscular disorders.'}, 'identificationModule': {'nctId': 'NCT05352620', 'briefTitle': 'Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Smart Box Accompanied With OT Equator Attachment in Retaining Immediately Loaded Inclined Implant Assisted Overdenture for Atrophic Maxilla', 'orgStudyIdInfo': {'id': 'Overdenture_2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implant assisted maxillary overdenture', 'description': 'Horseshoe Maxillary Complete overdenture construction (Stabilizing and connecting the Smart Box housing)', 'interventionNames': ['Other: Implant assisted maxillary overdenture']}], 'interventions': [{'name': 'Implant assisted maxillary overdenture', 'type': 'OTHER', 'description': 'For each patient, an implant assisted maxillary overdenture will be fabricated using a minimally invasive flapless surgical technique with OT-Equator and Smart Box attachment', 'armGroupLabels': ['Implant assisted maxillary overdenture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}