Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-15 @ 2:53 AM
Study NCT ID:
NCT05402202
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2022-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-22', 'studyFirstSubmitDate': '2022-05-30', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scanning time (healing abutment-scan peg vs scan body)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The scanning time by intraoral scanner will be recorded in both groups'}, {'measure': 'Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The proximal contacts will be evaluated with dental floss\n\n1. Open: an open contact will be reported if there is no resistance against floss\n2. Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion.\n3. Tight: a tight contact will be reported if it prevents the passage of floss through the proximal contact point.\n\nThe percentage of proximal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.'}, {'measure': 'Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'An evaluation of occlusion will be executed with 2 layers of shim stock of 12µ.\n\n1. No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment.\n2. Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment.\n3. Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major.\n4. Out of occlusion: If the shim stock passes without resistance after clenching, an open contact will be reported.\n\nThe percentage of occlusal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.'}, {'measure': 'Evaluation of occlusion by digital occlusal analyzer', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'occlusal force of implant-supported restorations will be measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implants, Single-Tooth']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body', 'detailedDescription': 'Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:\n\n 1. Adequate interarch and mesiodistal space.\n 2. Proper bone height and width.\n 3. Adequate zone of keratinized tissue (at least 2 mm)\n\nExclusion Criteria:\n\n1. Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases\n2. A history of head and neck radiation treatment.\n3. Periodontal diseases.\n4. Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32)\n5. Parafunctional habits.\n6. Malocclusion.'}, 'identificationModule': {'nctId': 'NCT05402202', 'briefTitle': 'Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations', 'orgStudyIdInfo': {'id': 'IORG0008831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healing abutment with scan peg (Neoss implant system, Harrogate, England)', 'description': '12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg', 'interventionNames': ['Other: Healing abutment with scan peg (Neoss implant system, Harrogate, England)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Customized healing abutment', 'description': '12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment', 'interventionNames': ['Other: Customized healing abutment']}], 'interventions': [{'name': 'Healing abutment with scan peg (Neoss implant system, Harrogate, England)', 'type': 'OTHER', 'description': '12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg', 'armGroupLabels': ['Healing abutment with scan peg (Neoss implant system, Harrogate, England)']}, {'name': 'Customized healing abutment', 'type': 'OTHER', 'description': '12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment fabricated by intraoral scanning by scan body', 'armGroupLabels': ['Customized healing abutment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21527', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer, Department of Prosthodontics, Faculty of Dentistry', 'investigatorFullName': 'Rania Elsayed', 'investigatorAffiliation': 'Alexandria University'}}}}