Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-01-02 @ 9:29 AM
Study NCT ID:
NCT03713918
Status:
UNKNOWN
Last Update Posted:
2018-10-30
First Post:
2018-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'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'], 'maskingDescription': 'Participants and outcome assessor will be blinded to avoid performance, detection and analysis bias. Only main investigator will be aware of the allocated patients in each group and the specific type of intervention given to every patient'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients requiring posterior single crowns or endocrowns'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent caries', 'timeFrame': 'one year', 'description': 'It will be assessed using United States public health service (USPHS) criteria.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'one year', 'description': 'Questionnaire regarding patient satisfaction will be evaluated by the assessor'}, {'measure': 'Retention', 'timeFrame': 'one year', 'description': 'retention of the two groups will be assessed using the modified United States public health service (USPHS) criteria (Alpha,Bravo,Charlie)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endodontically Treated Teeth']}, 'descriptionModule': {'briefSummary': "Coronal retention of the restoration of RCT teeth is usually compromised, thus intraradicular posts combined or not with core material may be required.\n\nThe drawbacks of the conventional treatment created a necessary demand to have alternative treatment options. Among these options is the endocrown restoration. The pulpal chamber cavity provides retention and stability. Its trapezoidal shape in mandibular molars and triangular shape in maxillary molars increase the restoration's stability. The saddle form of the pulpal floor increases stability. This anatomy, along with the adhesive qualities of the bonding material, make no need for additional preparation or further use of post-involving root canals.", 'detailedDescription': "Aim of the study:\n\nThe aim of this study is to evaluate the effect of using reinforced lithium silicate endocrowns on the recurrent caries, patient satisfaction and retention in comparison to post retained reinforced lithium silicate crowns.\n\nThe study is held to evaluate recurrent caries,patient satisfaction and retention of endodontically treated teeth restored with Endocrowns versus Post Retained Crowns using Reinforced Lithium Silicate after one year follow up .\n\nThe clinical performance of ceramic endocrowns showed a survival rate of 99 % and the success rate of 89.9 % in a 10 year retrospective study done by Bellflamme et al. 2017.\n\nEndocrowns; a recently developed line of treatment, take the advantage of the rapidly growing discipline of adhesion to glass ceramics. As the retention and recurrent caries are decisive factors in the prognosis of a restoration' they have to be thoroughly investigated.\n\nPatients with endodontically treated lower first molars will be collected.after teeth preparation to receive endocrowns and crowns ,secondary impressions will be taken .The Patients will be divided randomly into two groups .One group will receive reinforced Lithium Silicate Endocrowns (intervention)and the other group will receive reinforced Lithium Silicate Crowns (control) retained with fiber posts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patient age range of 18-55 years.\n\n * Patients physically and psychologically able to tolerate conventional restorative procedures.\n * Co-operative patients approving to participate in this trial.\n * Patients with root canal treated lower first molars requiring full coverage restoration.\n * Patients willing to return for follow-up examinations and assessments.\n * Endodontically treated teeth with absence of clinical diagnosis of periapical pathosis, fistula, swelling of periodontal tissues, abnormal tooth mobility and history of sensitivity to pressure\n\nExclusion Criteria:\n\n* Patients in the growth stage with partially erupted teeth.\n* Patients with poor oral hygiene.\n* Disabilities which will not be cooperative patient for the study.\n* Systemic diseases or severe medically compromised patients as uncontrolled diabetes or oral cancer.\n* Patients suffer from parafunctional habits\n* Teeth with fractured roots\n* Teeth with lesions extending apical to the cemento-enamel junction\n* Poor oral hygiene.'}, 'identificationModule': {'nctId': 'NCT03713918', 'briefTitle': 'Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Assessment of Retention, Patient Satisfaction and Recurrent Caries of Endocrowns Versus Post Retained Crowns Using Reinforced Lithium Silicate.', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-10-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reinforced lithium silicate endocrown', 'description': 'Device: Endocrown restoration', 'interventionNames': ['Other: Reinforced lithium silicate endocrowns']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reinforced lithi silicate crn e post', 'description': 'Device: Post retained reinforced lithium silicate crowns', 'interventionNames': ['Other: Post retained reinforced lith silicate crn']}], 'interventions': [{'name': 'Reinforced lithium silicate endocrowns', 'type': 'OTHER', 'otherNames': ['endocrowns'], 'description': 'The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with reinforced lithium silicate and cemented with self adhesive cement', 'armGroupLabels': ['Reinforced lithium silicate endocrown']}, {'name': 'Post retained reinforced lith silicate crn', 'type': 'OTHER', 'description': 'The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and reinforced lithium silicate crown will be cemented with self adhesive cement.', 'armGroupLabels': ['Reinforced lithi silicate crn e post']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer,fixed prosthodontic department,faculty of dentistry', 'investigatorFullName': 'Sireen Taher Meheshi', 'investigatorAffiliation': 'Cairo University'}}}}