Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:15 PM
Study NCT ID:
NCT07456995
Status:
COMPLETED
Last Update Posted:
2026-03-09
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Mandibular Posterior Zirconia Crowns With Different Ti-Base Surface Treatments.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}, {'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Who will be blinded after assignment to interventions:\n\nTrial participants Outcome assessors Data analysts Statistician How blinding will be achieved: Blinding will be maintained by using identical looking materials and procedures for both intervention groups and coding the groups as Ⅰ and Ⅱ and Ⅲ without revealing the content.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a three-arm, parallel-group, superiority randomized controlled clinical trial. Participants are allocated with a 1:1 ratio to one of three groups to evaluate the impact of different Ti-Base abutment surface treatments on the survival of screw-retained zirconia crowns.\n\nThe three study arms are:\n\nControl Group (Group I): Titanium base abutment without any surface treatment.\n\nIntervention Group II: Titanium base abutment treated with Tribochemical silica coating (CoJet Sand) at 2.0 bar pressure.\n\nIntervention Group III: Titanium base abutment treated with Tribochemical silica coating (CoJet Sand) at 2.0 bar pressure followed by the application of a primer (Z-Prime Plus).\n\nThe primary outcome is the survival of the restorations measured using modified USPHS criteria over a 1-year follow-up period . secondary outcomes include biological parameters measured by the modified plaque index (mPI) and modified Sulcus Bleeding Index (mSBI).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of screw-retained zirconia crown restorations.', 'timeFrame': 'Baseline (1 week post-cementation), 6 months, and 12 months.', 'description': 'Evaluation of the restoration using modified United States Public Health Service (USPHS) criteria, specifically assessing fracture behavior, decementation, anatomical form, and marginal adaptation.'}], 'secondaryOutcomes': [{'measure': 'Modified Plaque Index (mPI)', 'timeFrame': '12 months.', 'description': 'Evaluation of peri-implant health using the modified Plaque Index, scored from 0 to 3.'}, {'measure': 'Modified Sulcus Bleeding Index (mSBI)', 'timeFrame': '12 months', 'description': 'Evaluation of peri-implant health using the modified Sulcus Bleeding Index, scored from 0 to 3.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ti-Base Abutment', 'Zirconia Crown', 'Tribochemical Silica Coating', 'Surface Treatment', 'Screw-Retained Restoration'], 'conditions': ['Jaw, Edentulous, Partially', 'Tooth Loss', 'Molar Teeth', 'Dental Implant']}, 'referencesModule': {'references': [{'pmid': '40884315', 'type': 'BACKGROUND', 'citation': 'Oktay F, Yanikoglu N, Bayindir F. Investigation of the Effect of Different Surface Treatments Applied to Titanium Dental Implant Abutments on the Retention of CAD/CAM Zirconium-Supported Ceramic Crowns. Niger J Clin Pract. 2025 Aug 1;28(8):880-888. doi: 10.4103/njcp.njcp_41_24. Epub 2025 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial evaluates how different surface treatments on a metal base (Ti-Base) affect the success of dental crowns on implants. Patients receiving a zirconia crown for a missing lower back tooth are divided into three groups: one group receives no special treatment on the metal base, one group receives a silica coating, and the third receives both a silica coating and a chemical primer. The study monitors these crowns for one year to see which treatment best prevents the crown from coming loose or breaking, while also checking the health of the surrounding gums.', 'detailedDescription': 'This is a three-arm, parallel-group, superiority randomized controlled trial. The research question addresses the impact of silica coating (CoJet Sand) and primer (Z-Prime Plus) on the survival of mandibular posterior screw-retained zirconia crowns.+3The primary intervention involves treating the titanium base (Ti-Base) abutment surface using 30-mm $SiO\\_2-Al\\_2O\\_3$ particles at 2.0 bar pressure. The three groups are:Group I (Control): No surface treatment.Group II: Tribochemical silica coating alone.Group III: Tribochemical silica coating followed by Z-Prime Plus application.Survival is evaluated using modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Biological health is assessed via the modified plaque index (mPI) and modified Sulcus Bleeding Index (mSBI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 55 years\n* Missing mandibular first molar with opposing natural teeth\n* Good oral hygiene and general health (ASA I or II)\n* Smoking ≤ 10 cigarettes/day\n\nExclusion Criteria:\n\n* Poor oral hygiene\n* Severe wear facets, clenching, or bruxism\n* Heavy smokers (\\>10 cigarettes/day)'}, 'identificationModule': {'nctId': 'NCT07456995', 'acronym': 'RCT', 'briefTitle': 'Evaluation of Mandibular Posterior Zirconia Crowns With Different Ti-Base Surface Treatments.', 'organization': {'class': 'OTHER', 'fullName': 'October University for Modern Sciences and Arts'}, 'officialTitle': 'Clinical Evaluation of Mandibular Posterior Screw-retained Zirconia Crown With Various Ti-Base Abutment Surface Treatments: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'PRO 4.4.1.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group (Group I)', 'description': 'Patients in this group receive a screw-retained zirconia crown on a titanium base (Ti-Base) abutment that has received no surface treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group II', 'description': 'The surface of the titanium base abutment is treated with tribochemical silica coating using 30-μm $SiO\\_2-Al\\_2O\\_3$ particles (CoJet Sand) at 2.0 bar pressure before the zirconia crown is attached.', 'interventionNames': ['Device: Tribochemical silica coating.']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group III', 'description': 'The titanium base abutment surface is treated with tribochemical silica coating (30-μm $SiO\\_2-Al\\_2O\\_3$ particles at 2.0 bar pressure) followed by the application of a chemical primer (Z-Prime Plus).', 'interventionNames': ['Device: Tribochemical silica coating and Z-Prime Plus.']}], 'interventions': [{'name': 'Tribochemical silica coating.', 'type': 'DEVICE', 'otherNames': ['CoJet Sand.'], 'description': 'Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure.', 'armGroupLabels': ['Intervention Group II']}, {'name': 'Tribochemical silica coating and Z-Prime Plus.', 'type': 'DEVICE', 'otherNames': ['CoJet Sand and Z-Prime Plus.'], 'description': 'Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure, followed by the application of Z-Prime Plus primer.', 'armGroupLabels': ['Intervention Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14512', 'city': 'Giza', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'MSA University, Faculty of Dentistry', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Dina Elawady, PhD / Asst. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'MSA University, Faculty of Dentistry'}, {'name': 'Hesham Amr, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'MSA University, Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October University for Modern Sciences and Arts', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master candidate', 'investigatorFullName': 'MohamedTarek Abdeltawab Salam', 'investigatorAffiliation': 'October University for Modern Sciences and Arts'}}}}