Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-22 @ 5:25 PM
Study NCT ID:
NCT02931903
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lithium Disilicate Glass-ceramic Versus Hybrid Ceramic Superstructure Materials on Implant Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621297', 'term': 'VITA Enamic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival rate', 'timeFrame': '12 months', 'description': 'Implant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate'}], 'secondaryOutcomes': [{'measure': 'Crestal bone loss', 'timeFrame': '12 months', 'description': 'Crestal bone loss will be measured using a Cone Beam Computed tomography to measure the amount of bone resorbed from start date, and follow up for one year'}, {'measure': 'Peri-implant tissue response', 'timeFrame': '12 months', 'description': 'Bleeding index, probing depth and gingival index'}, {'measure': 'Patient satisfaction', 'timeFrame': '12 months', 'description': 'Patients will be asked to answer a questionnaire to know whether the procedure was not satisfied, accepted, or highly satisfied'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['implant supported restorations', 'IPS Emax (lithium disilicate glass-ceramic)', 'Vita Enamic (hybrid dental ceramic)', 'implant survival', 'peri-implant tissue response'], 'conditions': ['Prosthesis Survival']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of the newly introduced (hybrid dental ceramic) superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient satisfaction and crestal bone loss.', 'detailedDescription': "This study will be conducted on patients requiring single implant replacement in the maxillary premolar area, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University.\n\nAfter a period of healing of 6 months, an implant abutment of accurate diameter and angulation will be placed to fit precisely into the internal hex of the fixture after removal of the cover screw. The platform matched abutment will be then secured into its final position using the abutment screw. Alginate impression will be taken and poured into dental stone. Using the impression transfers, impressions with polyvinylsiloxane are taken. After taking the impressions, the Impression transfers are removed and fixed to the implant replica.\n\nSurgeons' assistants will be asked to open the sealed envelope containing the information regarding the crown placement. The impressions will be sent to dental laboratory with the result of the sealed envelope, for preparation of the future crowns, either vita enamic crowns or Ips e max crowns."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients \\> 18 yrs. Patients with missing teeth in the maxillary premolar region. Absence of any pathological condition in the recipient site.\n\nStabilization phase will be performed including:\n\n* Scaling\n* Debridement.\n* Elimination of all carious cavities and root canal treatment if needed.\n* Elimination of over-hanging restoration. Systemic condition of the subjects was evaluated according to dental modification of the Cornell medical index (Kerr and Millard 1966).\n\nPatients who are cooperative, motivated, and hygiene conscious. Patients should have adequate ridge width (\\>5mm).\n\nExclusion Criteria:\n\nPatients unable to undergo minor surgical procedure. Patients with history of drug abuse or metabolic drugs. Patients with history of psychiatric disorder. Patients with insufficient bone. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.\n\nPatients with any systemic condition that may contraindicate implant therapy. Patients that may have any habits that may jeopardize the osseo-integration process, such as heavy smoking and alcoholism.\n\nPatients with para-functional habits that produce overload on the implant such as bruxism and clenching.'}, 'identificationModule': {'nctId': 'NCT02931903', 'acronym': 'RCT', 'briefTitle': 'Lithium Disilicate Glass-ceramic Versus Hybrid Ceramic Superstructure Materials on Implant Stability', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of Lithium Disilicate Glass-ceramic (IPS Emax) Versus Hybrid Ceramic (Vita Enamic) Superstructure Materials on Implant Stability in Implant Supported Restorations', 'orgStudyIdInfo': {'id': 'CEBD-CU-2016-10-219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid superstructure', 'description': 'Vita Enamic is a hybrid ceramic, consisting of composite and ceramic. The ceramic; compatible and high aesthetics while the composite; resilient material with low modulus of elasticity which will absorb stress and therefore decrease load on bone and eventually decrease crestal bone loss', 'interventionNames': ['Other: Vita Enamic (hybrid dental ceramic)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ceramic superstructure', 'description': 'IPS Emax, is the mostly used ceramic superstructures in implant supported restorations.', 'interventionNames': ['Other: lithium disilicate glass-ceramic']}], 'interventions': [{'name': 'Vita Enamic (hybrid dental ceramic)', 'type': 'OTHER', 'otherNames': ['hybrid, resin nanoceramic'], 'description': 'Vita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology,', 'armGroupLabels': ['Hybrid superstructure']}, {'name': 'lithium disilicate glass-ceramic', 'type': 'OTHER', 'otherNames': ['Emax CAD, IPS Emax'], 'description': 'All ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology', 'armGroupLabels': ['Ceramic superstructure']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gihan El Naggar, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Sally Edward Fekry', 'investigatorAffiliation': 'Cairo University'}}}}