Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-01 @ 9:00 PM
Study NCT ID:
NCT04023357
Status:
UNKNOWN
Last Update Posted:
2019-08-08
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C063834', 'term': 'polyetheretherketone'}]}}, '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': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical evaluation of Retention', 'timeFrame': '1 Year', 'description': 'Retention of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)'}], 'primaryOutcomes': [{'measure': 'evaluation of marginal gap', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Marginal gap of the restorations assessed by Silicon replica technique using digital microscope'}], 'secondaryOutcomes': [{'measure': 'Clinical evaluation of marginal adaptation', 'timeFrame': '1 Year', 'description': 'Marginal adaptation of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)'}, {'measure': 'Clinical evaluation of fracture resistance', 'timeFrame': '1 Year', 'description': 'Fracture resistance of the restorations assessed clinically using dental mirror and probe according to the modified united states public health service criteria (USPHS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endodontically Treated Teeth']}, 'referencesModule': {'references': [{'pmid': '26110927', 'type': 'BACKGROUND', 'citation': 'Otto T, Mormann WH. Clinical performance of chairside CAD/CAM feldspathic ceramic posterior shoulder crowns and endocrowns up to 12 years. Int J Comput Dent. 2015;18(2):147-61. English, German.'}, {'pmid': '27692583', 'type': 'BACKGROUND', 'citation': 'Zoidis P, Bakiri E, Polyzois G. Using modified polyetheretherketone (PEEK) as an alternative material for endocrown restorations: A short-term clinical report. J Prosthet Dent. 2017 Mar;117(3):335-339. doi: 10.1016/j.prosdent.2016.08.009. Epub 2016 Sep 28.'}, {'pmid': '28955538', 'type': 'BACKGROUND', 'citation': 'Sevimli G, Cengiz S, Oruc MS. Endocrowns: review. J Istanb Univ Fac Dent. 2015 Apr 29;49(2):57-63. doi: 10.17096/jiufd.71363. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the marginal adaptation.so a less rigid material is needed. PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics, Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.\n\n.but the investigators have to know clinically it is performance , so the investigators are going to have Parallel groups in a randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects are required to be:\n\n* From 18-60 years old, and able to read and sign the informed consent document.\n* Physically and psychologically able to tolerate conventional restorative procedures\n* Have no active periodontal or pulpal diseases.\n* Willing to return for follow-up examinations and evaluation\n\nExclusion Criteria:\n\n* Patients in the growth stage with partially erupted teeth\n* Patient with fractured teeth of more than 50% enamel loss\n* Patients with poor oral hygiene and motivation\n* Pregnant women\n* Psychiatric problems or unrealistic expectations\n* Lack of opposite occluding dentition in the area intended for restoration'}, 'identificationModule': {'nctId': 'NCT04023357', 'briefTitle': 'Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.', 'orgStudyIdInfo': {'id': 'emax_peek'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEK', 'description': 'PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics,1 Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.\n\nYet clinical studies are needed to evaluate their clinical performance.', 'interventionNames': ['Other: PEEK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Emax', 'description': 'lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns', 'interventionNames': ['Other: Emax']}], 'interventions': [{'name': 'PEEK', 'type': 'OTHER', 'otherNames': ['BioHPP polyetheretherketones'], 'description': 'New polyetheretherketones material', 'armGroupLabels': ['PEEK']}, {'name': 'Emax', 'type': 'OTHER', 'otherNames': ['lithium disilicate glass ceramic'], 'description': 'standard etchable glass ceramic used for Endocrowns', 'armGroupLabels': ['Emax']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Youssef, M.D.S', 'role': 'CONTACT', 'email': 'Ahmedmohamedosman90@gmail.com', 'phone': '01064019439'}, {'name': 'Omaima Elmahlawy', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internal resident faculty of oral & dental medicine Cairo University', 'investigatorFullName': 'Ahmed mohamed osman Youssef', 'investigatorAffiliation': 'Cairo University'}}}}