Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT05973292
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessors and participants were blinded throughout the whole procedure. The dentist practitioner was responsible for all clinical procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients received their treatment at the same time. Follow-up periods were parallel for all participants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-07-26', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal Integrity', 'timeFrame': '3-6-9-12 Months', 'description': 'Using a dental mirror and a dental explorer, endocrowns were checked from every aspect, buccal, mesial, distal and lingual to detect any marginal discontinuity, fractures, or gaps. Endocrown evaluation was carried out against The Modified USPHS criteria'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': '3-6-9-12 Months', 'description': "Each patient was asked about his opinion regarding the restoration. Patients' answers and/or complaints were assessed and recorded against the USPHS criteria"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Dentistry, E-max, MDP, Zirconia'], 'conditions': ['Endodontically Treated Teeth', 'Anterior Teeth']}, 'descriptionModule': {'briefSummary': 'Rehabilitation of anterior endodontically treated teeth with significant coronal damage has been problematic. Adopting endocrown design to treat teeth with this condition is still under investigation. To address this issue, the USPHS criteria were adopted to assess the anterior endocrown restorations manufactured using various ceramic materials and cemented with different protocols.', 'detailedDescription': "40 participants with anterior endodontically treated maxillary central incisors were enrolled to restore their teeth with esthetic restorations Patients were divided into two groups, zirconia and e-max groups. Each group was, further subdivided into two groups following the cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and 18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction and potential postoperative discomfort were also assessed and recorded during the same periods. All qualitative data were displayed as frequency (N) and Percentages (%). The chi-square test was utilized for qualitative data comparisons.\n\nResults:\n\nAs to marginal integrity and patient satisfaction, no significant difference were revealed regarding all scores at different intervals as P\\>0.05.\n\nConclusions:\n\nAccording to the findings of this study, ceramic endocrowns offer a promising restorative solution for the rehabilitation of anterior endodontically treated teeth. Additionally, regardless of the presence of the MDP monomer in its composition, using adhesive resin cement achieved highly successful results when used with MDP-based ceramic primers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Freshly extracted teeth.\n\n * Completely formed apices\n * Minimum root length of 14mm (± 0.5) measured from the cement-enamel junction to the root apex.\n * Straight roots.\n * Teeth with single root canal.\n * Sound teeth with no cracks or fractured parts in its crown or root.\n * Absence of any carious lesions.\n * No signs of internal or external root resorption.\n * Similar bucco-lingual (BL) and mesio-distal (MD) dimensions as determined with a digital caliper.\n\nExclusion Criteria:\n\n* • Previously endodontically treated teeth.\n\n * Markedly curved roots.\n * Root contains more than one canal.\n * Presence of canal calcifications or pulp stones.\n * Internal or external root resorption.\n * Presence of cracks, fractures or caries.'}, 'identificationModule': {'nctId': 'NCT05973292', 'briefTitle': 'Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations', 'orgStudyIdInfo': {'id': 'M01160321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group ZA', 'description': 'Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.', 'interventionNames': ['Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate']}, {'type': 'EXPERIMENTAL', 'label': 'Ggroup ZB', 'description': 'Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.', 'interventionNames': ['Other: Non MDP containg resin cement']}, {'type': 'EXPERIMENTAL', 'label': 'Group EA', 'description': 'Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.', 'interventionNames': ['Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate']}, {'type': 'EXPERIMENTAL', 'label': 'Group EB', 'description': 'Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.', 'interventionNames': ['Other: Non MDP containg resin cement']}], 'interventions': [{'name': 'resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate', 'type': 'OTHER', 'otherNames': ['Panavia SA'], 'description': 'Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max', 'armGroupLabels': ['Group EA', 'Group ZA']}, {'name': 'Non MDP containg resin cement', 'type': 'OTHER', 'otherNames': ['Duo-link Universal'], 'description': 'Adhesive resin cement not containing an MDP agent', 'armGroupLabels': ['Ggroup ZB', 'Group EB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry,Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Lamia Dawood, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry', 'investigatorFullName': 'Nehal Samra', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}