Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-28 @ 12:39 AM
Study NCT ID:
NCT05250232
Status:
UNKNOWN
Last Update Posted:
2022-02-22
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-08-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of fracture resistance', 'timeFrame': 'one year', 'description': 'fracture resistance of restorations postoperatively: assessment of the restoration for fracture resistance , by using Measuring device Modified United States Public Health Service (MUSPHS) parameters were used to compare the restorations at baseline and final examination use explorer Measuring unit .Discrete(scores)\n\n1. alpha no evidence of fracture\n2. bravo evidence of fracture'}], 'secondaryOutcomes': [{'measure': 'evaluation of marginal adaptation', 'timeFrame': '1 year', 'description': 'marginal adaptation of restorations postoperatively assessment by Measuring device Modified USPHS Criteria Measuring unit .Discrete(scores) use explorer\n\n1. alpha no visible evidence of ditching along the margin\n2. bravo visible evidence of ditching along the margin not extending to the DE junction\n3. charlie mismatch between restoration and tooth structure within the normal range of color, shade ,translucency'}, {'measure': 'evaluation of patient satisfaction to the onlay restoration through questioning the patient about pain during eating , acceptability ,sensitivity', 'timeFrame': '1 year', 'description': "patient satisfaction of restoration use Questionnaire VAS\\* Measuring device Measuring unit Numerical(discrete) ('0' unsatisfied-'10' satisfied)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Decay']}, 'descriptionModule': {'briefSummary': 'the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Inclusion criteria:\n\nAll subjects are required to be:\n\n1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:\n\n1. Decayed teeth\n2. Teeth restored with defected filling restorations\n3. Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria\n\n 1. Patient less than 18 or more than 50 years\n 2. Patient with active resistant periodontal diseases\n 3. Patients with poor oral hygiene and uncooperative patients\n 4. Pregnant women\n 5. Patients in the growth stage with partially erupted teeth\n 6. Psychiatric problems or unrealistic expectations\n 7. Lack of opposing dentition in the area of interest\n\n \\-\n\n \\-'}, 'identificationModule': {'nctId': 'NCT05250232', 'briefTitle': 'One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays', 'orgStudyIdInfo': {'id': 'resala'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'onlays conservative', 'description': 'conservative onlays preparation with partial cusp coverage only defective cusps', 'interventionNames': ['Other: onlays conservative']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'onlays conventional', 'description': 'onlays preparation design conventional as all cusps covered with shoulder finish line preparation', 'interventionNames': ['Other: onlays conventional']}], 'interventions': [{'name': 'onlays conservative', 'type': 'OTHER', 'description': 'Partial coverage of cusps with shoulder finish line', 'armGroupLabels': ['onlays conservative']}, {'name': 'onlays conventional', 'type': 'OTHER', 'description': 'all coverage of cusps as overlay with shoulder finish line', 'armGroupLabels': ['onlays conventional']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Howaida Elhagrasy, M.D.S', 'role': 'CONTACT', 'email': 'howayda.elhagrasy@dentistry.cu.edu.eg', 'phone': '01006890707'}, {'name': 'Eman Hussein', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lereture must university', 'investigatorFullName': 'howaida ahmed el-hagrasy', 'investigatorAffiliation': 'Cairo University'}}}}