Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04366895
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2020-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D -Printed Single Implant Overdentures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-06', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-25', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival', 'timeFrame': '1 year', 'description': 'The implants were considered surviving if they were clinically stable, functioning without any mobility'}], 'secondaryOutcomes': [{'measure': 'Survival rate of overdentures', 'timeFrame': '1 year', 'description': 'urvival rate of overdentures: (calculated by Incidence of mid-line fracture)'}, {'measure': 'maximum biting force (MBF)', 'timeFrame': '1 year', 'description': 'MBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Mouth']}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.', 'detailedDescription': 'Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.\n\nMethods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "inclusion criteria\n\n* the participant should be completely edentulous ranging in age from 35 to 75 years\n* Angle's class I skeletal relationship\n* normal facial symmetry\n* adequate inter-arch space not less than 12mm\n* should be a cooperative patient -\n\nExclusion Criteria:\n\n* temporomandibular disorders\n* uncontrolled diabetes\n* bleeding disorders or anticoagulant therapy\n* flabby tissues or sharp mandibular residual ridge\n* neuromuscular disorders\n* Angle's class II and III skeletal relationship.\n* Patients who were heavy smokers\n* chemotherapy or radiotherapy or with severe psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT04366895', 'briefTitle': '3D -Printed Single Implant Overdentures', 'organization': {'class': 'OTHER', 'fullName': 'October University for Modern Sciences and Arts'}, 'officialTitle': '3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'MSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'Participants in control group (Group-A) received conventional manufactured implant overdenture', 'interventionNames': ['Other: conventional single implant overdenture']}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.', 'interventionNames': ['Other: 3d printed single implant overdenture']}], 'interventions': [{'name': 'conventional single implant overdenture', 'type': 'OTHER', 'description': 'conventional manufactured implant overdenture', 'armGroupLabels': ['control']}, {'name': '3d printed single implant overdenture', 'type': 'OTHER', 'description': 'CAD-CAM manufactured implant overdenture.', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12451', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Msa Uni', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Dina Elawady, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October University for Modern Sciences and Arts', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Prosthodontics (principal investigator)', 'investigatorFullName': 'Dina ElAwady', 'investigatorAffiliation': 'October University for Modern Sciences and Arts'}}}}