Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
Study NCT ID:
NCT03562858
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative hypersensitivity at baseline', 'timeFrame': '10 minutes', 'description': 'The post-operative hypersensitivity assessment will be performed at baseline , using visual analogue scale (VAS) for both intervention and control group . The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity'}, {'measure': 'Post-operative hypersensitivity one week after temporization', 'timeFrame': '1 week', 'description': 'The post-operative hypersensitivity will be assessed one week after temporization for both intervention and control group using the visual analogue scale VAS .The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity'}, {'measure': 'Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration', 'timeFrame': '1 week', 'description': 'The post-operative hypersensitivity will be assessed using visual analogue scale VAS 1 week after cementation of the indirect tooth coloured restoration. The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity, the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypersensitivity Dentin']}, 'descriptionModule': {'briefSummary': 'PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Extensive carious lesions indicated for indirect restorations\n* Lower first molars\n* Age of patients range is 18 -50 years\n* Patients have not received antibiotic therapy for 1 month before sampling\n* Males or Females (Both genders)\n* Patients with Good oral hygiene\n* Co-operative patients approving the trial\n\nExclusion Criteria:\n\n* Pregnancy\n* Systemic disease or severe medical\n* Patients having complications as:\n\nPeriodontal problems Mobile teeth, arrest caries and non-vital teeth\n\n* Heavy smoking patients\n* Xerostomia\n* Lack of compliance'}, 'identificationModule': {'nctId': 'NCT03562858', 'briefTitle': 'Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-05-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed dentine sealing', 'interventionNames': ['Procedure: Delayed dentin sealing protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Immediate dentin sealing', 'interventionNames': ['Procedure: Immediate dentin sealing protocol']}], 'interventions': [{'name': 'Immediate dentin sealing protocol', 'type': 'PROCEDURE', 'description': 'Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation', 'armGroupLabels': ['Immediate dentin sealing']}, {'name': 'Delayed dentin sealing protocol', 'type': 'PROCEDURE', 'description': 'Sealing the dentin just prior to cementation', 'armGroupLabels': ['Delayed dentine sealing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Hoda Fouda', 'role': 'CONTACT', 'email': 'Hoda.omar@dentiatry.cu.edu.eg', 'phone': '01003786531'}, {'name': 'Hoda Fouda, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of dentistry cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hoda Fouda, Master', 'role': 'CONTACT', 'email': 'Hoda.omar@dentistry.cu.edu.eg', 'phone': '01003786531'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'hoda omar tawfeek hussien fouda', 'investigatorAffiliation': 'Cairo University'}}}}