Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-24 @ 8:50 AM
Study NCT ID:
NCT02110550
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2014-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New Design of Crowns in the Posterior Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-02', 'studyFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Marginal Adaptation', 'timeFrame': 'at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application', 'description': 'The presence of marginal adaptation means that the restoration margins cannot be distinguished, the probe cannot find a step between the margins and the surrounding tissue, and no discoloration visible.'}, {'measure': 'Change in the Anatomic Form', 'timeFrame': 'at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application', 'description': 'The anatomic form is considered satisfactory when the crown has a correct contour with tight proximal contact, no worn facets on restorations and no worn facets on opposing teeth.'}], 'secondaryOutcomes': [{'measure': 'Change in the Retention Status', 'timeFrame': 'at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application', 'description': 'Retention loss is considered when the crown becomes loose or mobile.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endocrown', 'marginal adaptation', 'anatomic form', 'retention loss', 'IPS.emmax crowns'], 'conditions': ['Broken Down Molars', 'IPS-emmax Crowns']}, 'referencesModule': {'references': [{'pmid': '20648740', 'type': 'BACKGROUND', 'citation': 'Bernhart J, Brauning A, Altenburger MJ, Wrbas KT. Cerec3D endocrowns--two-year clinical examination of CAD/CAM crowns for restoring endodontically treated molars. Int J Comput Dent. 2010;13(2):141-54. English, German.'}, {'pmid': '21942234', 'type': 'BACKGROUND', 'citation': 'Biacchi GR, Basting RT. Comparison of fracture strength of endocrowns and glass fiber post-retained conventional crowns. Oper Dent. 2012 Mar-Apr;37(2):130-6. doi: 10.2341/11-105-L. Epub 2011 Sep 26.'}, {'pmid': '11725673', 'type': 'BACKGROUND', 'citation': 'Bindl A, Mormann WH. Clinical evaluation of adhesively placed Cerec endo-crowns after 2 years--preliminary results. J Adhes Dent. 1999 Autumn;1(3):255-65.'}, {'pmid': '11740960', 'type': 'BACKGROUND', 'citation': 'Fischer H, Marx R. Fracture toughness of dental ceramics: comparison of bending and indentation method. Dent Mater. 2002 Jan;18(1):12-9. doi: 10.1016/s0109-5641(01)00005-7.'}]}, 'descriptionModule': {'briefSummary': 'Background: no randomized controlled trial has tried to compare treatment outcomes between the IPS.emmax endocrowns and the IPS.emmax conventional crowns .\n\nObjective: to investigate the clinical performance of the IPS.emmax endocrowns and the IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at the baseline assessment using a modified US Public Health Service (USPHS) criteria.\n\nParticipants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning. Forty patients will be recruited according to specific inclusion criteria. Randomization will be performed using computer-generated tables; allocation will be concealed using sequentially numbered opaque and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60 years). They will be randomly distributed into two groups with 20 patients in each group (1:1 allocation ratio).\n\nIntervention: Excessively damaged and endodontically treated molars will be restored with IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.\n\nMain outcome measure: marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified (USPHS) at six assessment times during an 18-month observation period.\n\nAssessor blinding will be employed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 20 to 60 years old\n* Good oral hygiene\n* Gingival index (GI) equal 0\n* Plaque index (PI) equal 0 or 1\n* Primary acceptation and commitment to the trail\n\nInclusion criteria of molars:\n\n* Two remaining axial walls at least.\n* 0.5 mm above the gingival line at least for damaged axial walls.\n* Good endodontic treatment and apical seal\n* First and second upper and lower molars only.\n* Against teeth could be natural or crowned.\n\nExclusion Criteria:\n\n* Patients with an open bite or cross bite.\n* Bruxism\n* Periodontitis\n* Gingival hyperplasia'}, 'identificationModule': {'nctId': 'NCT02110550', 'briefTitle': 'Evaluation of a New Design of Crowns in the Posterior Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Evaluation of IPS E.Max-CAD Endocrown in Molars Compared to the Conventional Design', 'orgStudyIdInfo': {'id': 'UDDS-FixPro-01-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'IPS.emmax crown'}, {'type': 'EXPERIMENTAL', 'label': 'IPS.emmax endocrown', 'description': 'Patients with excessively undermined and endodontically treated molars will receive the IPS.emmax endocrown as the restoration of choice.', 'interventionNames': ['Other: IPS.emmax endocrown']}], 'interventions': [{'name': 'IPS.emmax endocrown', 'type': 'OTHER', 'armGroupLabels': ['IPS.emmax endocrown']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DM20AM18', 'city': 'Damascus', 'state': 'Rif-dimashq Governorate', 'country': 'Syria', 'facility': 'Department of Fixed Prosthodontics, University of Damsacus'}, {'zip': 'DM20AM18', 'city': 'Damascus', 'state': 'Rif-dimashq Governorate', 'country': 'Syria', 'facility': 'University of Damascus Dental School'}], 'overallOfficials': [{'name': 'Rana Dallool, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Damascus Dental School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}