Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-04-08 @ 8:50 PM
Study NCT ID:
NCT07005167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': 'From cementation of endocrown, then at 6 months, 12 months and 18 months', 'description': 'Modified USPHS criteria'}], 'secondaryOutcomes': [{'measure': 'Restoration Failure', 'timeFrame': 'From cementation of endocrown, then at 6 months, 12 months and 18 months', 'description': 'Modified USPHS criteria'}, {'measure': 'Marginal Adaptation', 'timeFrame': 'From cementation of endocrown, then at 6 months, 12 months and 18 months', 'description': 'Modified USPHS criteria'}, {'measure': 'Wear of Opposing Enamel', 'timeFrame': 'From cementation of endocrown, then at 6 months, 12 months and 18 months', 'description': 'Digital software (Geomagic)'}, {'measure': 'Surface Texture', 'timeFrame': 'From cementation of endocrown, then at 6 months, 12 months and 18 months', 'description': 'Modified USPHS criteria'}, {'measure': 'Color Match', 'timeFrame': 'From cementation of endocrown, then at 6 months, 12 months and 18 months', 'description': 'Modified USPHS criteria'}, {'measure': 'Luster of Restoration', 'timeFrame': 'From cementation, then at 6 months, 12 months and 18 months', 'description': 'Modified USPHS criteria'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'From cementation, then at 6 months, 12 months and 18 months', 'description': 'VAS (Questionnaire)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hybrid ceramics', 'cerasmart', 'HC hard blocks'], 'conditions': ['Endocrown Restoration']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the clinical success rate (measured by retention) of endo-crowns fabricated from two hybrid ceramic materials (HC Hard blocks ) versus (Cerasmart) at 6, 12, and 18 months.\n\nSecondary Objectives are:\n\n1. To compare the incidence of restoration failures between the two materials\n2. To assess marginal adaptation and marginal discoloration over time\n3. To evaluate wear of opposing enamel quantitatively\n4. To compare surface texture, color match, and luster between materials\n5. To determine patient satisfaction with both types of restorations It will be a randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥21 years\n2. Good general health (ASA I or II)\n3. Willing and able to provide informed consent\n4. Committed to follow-up appointments for 18 months\n5. Root canal treated molars requiring restoration\n6. Adequate remaining tooth structure:\n\n * Minimum 2mm ferrule height\n * Sufficient wall thickness (≥1.5mm)\n * At least 2 remaining walls\n7. Opposing natural dentition or fixed prosthesis\n8. Adequate periodontal health:\n\n * Probing depth ≤4mm\n * No bleeding on probing\n9. Good oral hygiene with plaque score ≤20%\n10. Sufficient mouth opening for clinical procedures\n11. Normal occlusion and acceptable interocclusal space\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Severe bruxism or parafunctional habits\n3. Active periodontal disease\n4. Active caries or inadequate oral hygiene\n5. Less than 2mm ferrule height after preparation\n6. Apical pathology or inadequate root canal treatment\n7. Tooth mobility grade II or III\n8. Known allergy to materials used\n9. Uncontrolled diabetes (HbA1c \\>7.0%)\n10. Radiation therapy in head and neck region\n11. Temporomandibular joint disorders\n12. History of poor compliance with dental appointments\n13. Heavy smokers (\\>10 cigarettes/day)\n14. Chronic use of medications affecting salivary flow\n15. Unable to understand study requirements\n16. Evidence of pulpal or periapical pathology'}, 'identificationModule': {'nctId': 'NCT07005167', 'briefTitle': 'Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '240789'}, 'secondaryIdInfos': [{'id': 'Shofu Inc,', 'type': 'OTHER', 'domain': 'Shofu Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Outpatients with endo-treated molars that will be restored with HC hard hybrid ceramic endocrowns', 'interventionNames': ['Procedure: endocrowns']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'utpatients with endo-treated molars that will be restored with Cerasmart endocrowns', 'interventionNames': ['Procedure: endocrowns']}], 'interventions': [{'name': 'endocrowns', 'type': 'PROCEDURE', 'description': 'endocrowns made of HC hard blocks or cerasmart blocks to restore endo treated molars', 'armGroupLabels': ['Outpatients with endo-treated molars that will be restored with HC hard hybrid ceramic endocrowns']}, {'name': 'endocrowns', 'type': 'PROCEDURE', 'description': 'endocrowns made of Cerasmart blocks to restore endo treated molars', 'armGroupLabels': ['utpatients with endo-treated molars that will be restored with Cerasmart endocrowns']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Faculty of dentistry, cairo university', 'role': 'CONTACT', 'email': 'rec@dentistry.cu.edu.eg', 'phone': '+223642705', 'phoneExt': '543'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Nada Farid Nada Farid Shehab, PhD', 'role': 'CONTACT', 'email': 'nada.farid@dentistry.cu.edu.eg', 'phone': '+201223402909'}, {'name': 'Omnia Omnia Nabil, Lecturer Fixed Prosthodontics', 'role': 'CONTACT', 'phone': '+201222201179'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Nada Ahmed Farid Zaki Shehab', 'investigatorAffiliation': 'Cairo University'}}}}