Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-28 @ 12:39 AM
Study NCT ID:
NCT04729569
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2021-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2021-01-24', 'studyFirstSubmitQcDate': '2021-01-27', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Marginal adaptation', 'timeFrame': '1 year', 'description': 'Evaluation using Modified USPHS criteria'}], 'primaryOutcomes': [{'measure': 'Position of the margin of the restoration in relation to the gingival margin position', 'timeFrame': '1 year', 'description': 'Scoring proposed by Paniz et al classified into either subgingival (not visible), equigingival (slightly visible) and supragingival (visible)'}], 'secondaryOutcomes': [{'measure': 'Bleeding on probing', 'timeFrame': '1 year', 'description': 'Scoring following Ainamo and Bay gingival bleeding index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Localized']}, 'referencesModule': {'references': [{'pmid': '41145363', 'type': 'DERIVED', 'citation': 'El-Khayat H, Anwar EM, Nabil O, Aboushahba M. Gingival Recession and Marginal Adaptation of Zirconia Crowns with Two Subgingival Margin Designs: A Randomized Clinical Trial. J Contemp Dent Pract. 2025 Aug 1;26(8):767-775. doi: 10.5005/jp-journals-10024-3932.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.', 'detailedDescription': 'The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.\n\nGingival bleeding on probing will be evaluated before treatment. Preparation for all ceramic full coverage restoration will be performed according to manufacturer instructions by one operator. Type of finish line (whether feather edge or deep chamfer finish line) will be selected randomly according to a computer generated randomization list. Restorative margins will be placed subgingivally. Zirconia crowns will be fabricated for the prepared teeth and cemented using resin luting agent. At 6 months and 12 months after the cementation, restorative margin position relative to the gingival margin will be recorded. Bleeding on probing and marginal adaptation will also be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years to 50 years old\n* Dentate patients planned for a single full coverage restoration in the posterior area.\n* Patients with no active periodontal disease.\n* \\>2mm of keratinized tissue\n\nExclusion Criteria:\n\n* Smoking (\\>10 cigarettes a day)\n* Substance abuse history\n* Patients with poor oral hygiene and high caries index\n* Patients suffering from abnormal occlusal habits for example clenching or bruxism\n* Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive)\n* Current steroid/chemotherapy\n* Head and neck irradiation\n* Pregnancy\n* Inability or unwillingness to return for follow up visits.'}, 'identificationModule': {'nctId': 'NCT04729569', 'briefTitle': 'Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '161020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tested finish line preparation', 'description': 'Feather edge finish line preparation (Intervention)', 'interventionNames': ['Procedure: Feather edge finish line preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator finish line preparation', 'description': 'Deep chamfer finish line preparation (Comparator)', 'interventionNames': ['Procedure: Deep chamfer finish line preparation']}], 'interventions': [{'name': 'Feather edge finish line preparation', 'type': 'PROCEDURE', 'description': 'Tooth preparation with feather edge finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.', 'armGroupLabels': ['Tested finish line preparation']}, {'name': 'Deep chamfer finish line preparation', 'type': 'PROCEDURE', 'description': 'Tooth preparation with deep chamfer finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.', 'armGroupLabels': ['Comparator finish line preparation']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heba Ahmed Hassan El-Khayat', 'investigatorAffiliation': 'Cairo University'}}}}