Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03530020
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wear Characteristics and Clinical Performance of Lithium Silicate Versus Monolithic Zirconia Crowns.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057085', 'term': 'Tooth Wear'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036485', 'term': 'obsidian'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patient will receive a restoration with superior function, esthetics, and excellent clinical performance.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wear of all ceramic crowns and color matching', 'timeFrame': '12 month', 'description': '(Wear of ceramic crowns) of the two groups will be assessed using the 3D optical profilometer.'}, {'measure': 'color matching', 'timeFrame': '12 month', 'description': 'Color match of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:\n\n* Alpha (Excellent) ideal.\n* Bravo (Acceptable) less than ideal but no modifications required\n* Charlie (Acceptable but modifications needed) staining or other shade modifications required.\n* Delta (Unacceptable) remake.'}], 'secondaryOutcomes': [{'measure': 'Wear of enamel antagonist to all ceramic crowns', 'timeFrame': '12 month', 'description': 'wear of antagonist enamel of the two groups will be assessed using the 3D optical profilometer.'}, {'measure': 'Marginal adaptation', 'timeFrame': '12 month', 'description': 'of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:\n\n* Alpha (Excellent) ideal.\n* Bravo (Acceptable) less than ideal but no modifications required\n* Charlie (Acceptable but modifications needed) modifications required.\n* Delta (Unacceptable) remake.'}, {'measure': 'anatomic form', 'timeFrame': '12 month', 'description': 'of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:\n\n* Alpha (Excellent) ideal.\n* Bravo (Acceptable) less than ideal but no modifications required\n* Charlie (Acceptable but modifications needed) modifications required.\n* Delta (Unacceptable) remake.'}, {'measure': 'integrity of restoration', 'timeFrame': '12 month', 'description': 'of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:\n\n* Alpha (Excellent) ideal.\n* Bravo (Acceptable) less than ideal but no modifications required\n* Charlie (Acceptable but modifications needed) modifications required.\n* Delta (Unacceptable) remake.'}, {'measure': 'secondary caries', 'timeFrame': '12 month', 'description': 'of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:\n\n* Alpha (Excellent) ideal.\n* Bravo (Acceptable) less than ideal but no modifications required\n* Charlie (Acceptable but modifications needed) modifications required.\n* Delta (Unacceptable) remake.'}, {'measure': 'retention', 'timeFrame': '12 month', 'description': 'of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:\n\n* Alpha (Excellent) ideal.\n* Bravo (Acceptable) less than ideal but no modifications required\n* Charlie (Acceptable but modifications needed) modifications required.\n* Delta (Unacceptable) remake.'}, {'measure': 'opposing tooth sensitivity', 'timeFrame': '12 month', 'description': 'of the two groups will assessed using the modified United States public health service (USPHS) criteria as follows:\n\n* Alpha (Excellent) ideal.\n* Bravo (Acceptable) less than ideal but no modifications required\n* Charlie (Acceptable but modifications needed) modifications required.\n* Delta (Unacceptable) remake.'}, {'measure': 'gingival condition', 'timeFrame': '12 month', 'description': 'Gingival index by Visual inspection using Score from 0-3'}, {'measure': 'periodontal condition', 'timeFrame': '12 month', 'description': 'Periodontal index by Periodontal probe using Score from 0-4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['monolithic zirconia', 'tooth wear', 'all ceramic crown'], 'conditions': ['Enamel and Ceramics Wear']}, 'referencesModule': {'references': [{'pmid': '24392475', 'type': 'BACKGROUND', 'citation': 'Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.'}, {'pmid': '26962376', 'type': 'BACKGROUND', 'citation': 'Daou EE. Esthetic Prosthetic Restorations: Reliability and Effects on Antagonist Dentition. Open Dent J. 2015 Dec 31;9:473-81. doi: 10.2174/1874210601509010473. eCollection 2015.'}, {'pmid': '22240686', 'type': 'BACKGROUND', 'citation': 'Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 1. Assessment, treatment planning and strategies for the prevention and the passive management of tooth wear. Br Dent J. 2012 Jan 13;212(1):17-27. doi: 10.1038/sj.bdj.2011.1099.'}, {'pmid': '25985742', 'type': 'BACKGROUND', 'citation': 'Mundhe K, Jain V, Pruthi G, Shah N. Clinical study to evaluate the wear of natural enamel antagonist to zirconia and metal ceramic crowns. J Prosthet Dent. 2015 Sep;114(3):358-63. doi: 10.1016/j.prosdent.2015.03.001. Epub 2015 May 16.'}, {'pmid': '18505225', 'type': 'BACKGROUND', 'citation': 'Olivera AB, Marques MM. Esthetic restorative materials and opposing enamel wear. Oper Dent. 2008 May-Jun;33(3):332-7. doi: 10.2341/07-95.'}, {'pmid': '10588803', 'type': 'BACKGROUND', 'citation': 'Magne P, Oh WS, Pintado MR, DeLong R. Wear of enamel and veneering ceramics after laboratory and chairside finishing procedures. J Prosthet Dent. 1999 Dec;82(6):669-79. doi: 10.1016/s0022-3913(99)70008-9.'}, {'pmid': '23848069', 'type': 'BACKGROUND', 'citation': 'Burgess JO, Janyavula S, Lawson NC, Lucas TJ, Cakir D. Enamel wear opposing polished and aged zirconia. Oper Dent. 2014 Mar-Apr;39(2):189-94. doi: 10.2341/12-345-L. Epub 2013 Jul 12.'}, {'pmid': '23479579', 'type': 'BACKGROUND', 'citation': 'Preis V, Weiser F, Handel G, Rosentritt M. Wear performance of monolithic dental ceramics with different surface treatments. Quintessence Int. 2013 May;44(5):393-405. doi: 10.3290/j.qi.a29151.'}, {'pmid': '24199603', 'type': 'BACKGROUND', 'citation': 'Park JH, Park S, Lee K, Yun KD, Lim HP. Antagonist wear of three CAD/CAM anatomic contour zirconia ceramics. J Prosthet Dent. 2014 Jan;111(1):20-9. doi: 10.1016/j.prosdent.2013.06.002. Epub 2013 Nov 5.'}, {'pmid': '23328193', 'type': 'BACKGROUND', 'citation': 'Janyavula S, Lawson N, Cakir D, Beck P, Ramp LC, Burgess JO. The wear of polished and glazed zirconia against enamel. J Prosthet Dent. 2013 Jan;109(1):22-9. doi: 10.1016/S0022-3913(13)60005-0.'}, {'pmid': '24447258', 'type': 'BACKGROUND', 'citation': 'Stober T, Bermejo JL, Rammelsberg P, Schmitter M. Enamel wear caused by monolithic zirconia crowns after 6 months of clinical use. J Oral Rehabil. 2014 Apr;41(4):314-22. doi: 10.1111/joor.12139. Epub 2014 Jan 22.'}, {'pmid': '25257823', 'type': 'BACKGROUND', 'citation': 'Lawson NC, Janyavula S, Syklawer S, McLaren EA, Burgess JO. Wear of enamel opposing zirconia and lithium disilicate after adjustment, polishing and glazing. J Dent. 2014 Dec;42(12):1586-91. doi: 10.1016/j.jdent.2014.09.008. Epub 2014 Sep 23.'}, {'pmid': '28965115', 'type': 'BACKGROUND', 'citation': 'Samer MS, Faraz Q, Al-Dubai SAR, Vohra F, Abdullah H, Taiyeb-Ali TB, Saub R. Clinical Outcomes and Predictors of Satisfaction in Patients with Improved Lithium Disilicate All-Ceramic Crowns. Med Princ Pract. 2017;26(5):470-479. doi: 10.1159/000481864. Epub 2017 Oct 1.'}, {'pmid': '16315023', 'type': 'BACKGROUND', 'citation': 'Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.'}, {'pmid': '27277661', 'type': 'BACKGROUND', 'citation': 'Lohbauer U, Reich S. Antagonist wear of monolithic zirconia crowns after 2 years. Clin Oral Investig. 2017 May;21(4):1165-1172. doi: 10.1007/s00784-016-1872-6. Epub 2016 Jun 9.'}, {'pmid': '17727943', 'type': 'BACKGROUND', 'citation': 'Suputtamongkol K, Anusavice KJ, Suchatlampong C, Sithiamnuai P, Tulapornchai C. Clinical performance and wear characteristics of veneered lithia-disilicate-based ceramic crowns. Dent Mater. 2008 May;24(5):667-73. doi: 10.1016/j.dental.2007.06.033. Epub 2007 Aug 28.'}, {'pmid': '24980739', 'type': 'BACKGROUND', 'citation': 'Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.'}, {'pmid': '27198539', 'type': 'BACKGROUND', 'citation': 'Stober T, Bermejo JL, Schwindling FS, Schmitter M. Clinical assessment of enamel wear caused by monolithic zirconia crowns. J Oral Rehabil. 2016 Aug;43(8):621-9. doi: 10.1111/joor.12409. Epub 2016 May 20.'}, {'pmid': '11931220', 'type': 'BACKGROUND', 'citation': 'Landry RG, Jean M. Periodontal Screening and Recording (PSR) Index: precursors, utility and limitations in a clinical setting. Int Dent J. 2002 Feb;52(1):35-40. doi: 10.1111/j.1875-595x.2002.tb00595.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the wear characteristics and clinical performance of lithium silicate crowns in comparison to monolithic zirconia crowns.\n\nThe quality of the overall restorations as well as gingival tissues will be also evaluated according to modified United States Public Health Service (USPHS) criteria: (Marginal adaptation, color match, anatomic form, integrity of restoration, secondary caries, retention, tooth sensitivity, gingival index and periodontal index) at baseline, 6 months and 1 year', 'detailedDescription': 'Recently advances in ceramics have greatly improved the mechanical and optical properties of restorative materials to overcome the drawbacks of all ceramic restorations over decades such as fracture, chipping, crack, wear and delamination of veneer ceramics.\n\nUp to date despite the popularity of all ceramic restoration, the clinicians have been worried about the wear of tooth enamel antagonist to ceramic materials.\n\nThe wear properties of the ceramic restoration can affect the rate of wear of the antagonist enamel. So the wear resistance of ceramic restoration must be the same as enamel.\n\nExplanation for choice of the comparator:\n\nMonolithic zirconia attracts many dentists worldwide due to its excellent mechanical properties, biocompatibility and appreciate aesthetics. Some in vivo studies demonstrated the clinical success of monolithic zirconia restorations as an antagonist to natural enamel with good marginal adaptation, accepted contour, occlusion and minimum gingival response.\n\nBatson et al. studied the quality of CAD/CAM fabricated single tooth restorations (Ten zirconia restorations were compared to 12 metal ceramic and 10 lithium disilicate counterparts) .They found that were no significant differences between the studied crown systems. No difference of the gingival response among the different crown systems. Eighty percent of zirconia crowns needed no occlusal adjustment; also it showed the least amount of marginal discrepancy.\n\nLohbauer et al. evaluated the amount of wear on the antagonist occlusal surfaces of clinically placed monolithic zirconia premolar and molar crowns using optical profilometry after 2 years of cementation, they found that the mean volume loss for enamel antagonist contacts (n = 7) was measured to 361 μm and the mean of the maximum vertical loss to 204 μm. The mean volume loss for pure ceramic contacts (n = 10) was measured to 333 μm and the mean of the maximum vertical loss to 145 μm.\n\nMundhe et al.compared the wear of enamel opposing polished zirconia, glazed metal ceramic crowns and natural enamel as a control, one year after the cementation. They found that the occlusal wear of the antagonistic enamel one year after the cementation of metal ceramic crowns ranged from 69.20 ± 4.10 to 179.70 ± 8.09 μm, whereas, for zirconia crowns, it was from 42.10 ± 4.30 to 127.00 ± 5.03 μm.\n\nStober et al. reported that after 2 years of cementation of the monolithic zirconia crowns, Mean and maximum vertical loss of enamel in occlusal contact areas caused by monolithic zirconia (46 and 151 μm, respectively) was approximately double that caused by contralateral antagonistic enamel (19-26 and 75-115 μm, respectively).\n\nA lithium silicate glass ceramic (obsidian ceramic) is newly introduced to the market. After crystallization, it exhibits an ideal combination of esthetics and strength with translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns. Obsidian ceramic restorations are highly resistant to chipping unlike other ceramics, due to their monolithic composition and average flexural strength of 385 MPa. Also Obsidian Milling Block owes its good wear resistance due to a very high content of ultrafine nanometer-size crystalline structure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All subjects are required to be:\n\n 1. Age range of the patients from 21-50 years old; able to read and sign the informed consent document, illiterate patient will be avoided.\n 2. Patients able physically and psychologically to tolerate conventional restorative procedures.\n 3. Patients with no active periodontal or pulpal diseases, having teeth with good restorations.\n 4. Patients with teeth problems indicated for full coverage restoration (e.g. moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).\n 5. Patients with root canal treated teeth requiring full coverage restorations.\n 6. Presence of an opposing natural tooth which is non-restored or minimally restored. (Minimally restored is defined as teeth which have no restoration greater than a Class II a restoration)\n 7. The opposing arch doesn't have a full coverage restoration or a partial denture.\n 8. Patients willing to return for follow-up examinations and evaluation.\n\n Exclusion Criteria:\n\n <!-- -->\n\n 1. Patients with poor oral hygiene.\n 2. Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle bunch).\n 3. Patients have no opposite occluding dentition in the area intended for restoration\n 4. Patients suffer from Para functional habits or temporomandibular disorders. (as those patient may have wear which will affect the results)"}, 'identificationModule': {'nctId': 'NCT03530020', 'briefTitle': 'Wear Characteristics and Clinical Performance of Lithium Silicate Versus Monolithic Zirconia Crowns.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Wear Characteristics and Clinical Performance of Lithium Silicate Versus Monolithic Zirconia Crowns. (Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'enamel and ceramics wear'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'monolithic zirconia crowns', 'description': 'Monolithic zirconia attracts many dentists worldwide due to its excellent mechanical properties, biocompatibility and appreciate aesthetics', 'interventionNames': ['Other: monolithic zirconia crowns']}, {'type': 'EXPERIMENTAL', 'label': 'lithium silicate crowns', 'description': 'A lithium silicate glass ceramic is newly introduced to the market. After crystallization, it exhibits an ideal combination of aesthetics and strength with translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns.', 'interventionNames': ['Other: lithium silicate crowns']}], 'interventions': [{'name': 'monolithic zirconia crowns', 'type': 'OTHER', 'otherNames': ['katana zirconia, Kuraray Noritake , Japan'], 'description': 'full anatomical monolithic crowns', 'armGroupLabels': ['monolithic zirconia crowns']}, {'name': 'lithium silicate crowns', 'type': 'OTHER', 'otherNames': ['obsidian, Glide well Laboratories, USA'], 'description': 'lithium silicate glass ceramics are highly resistance to chipping', 'armGroupLabels': ['lithium silicate crowns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'country': 'Egypt', 'contacts': [{'name': 'Rasmia M salem, msc', 'role': 'CONTACT', 'email': 'rasmia.salem@yahoo.com', 'phone': '01024340442'}, {'name': 'Gihan El Nagar, professor', 'role': 'CONTACT', 'email': 'drgigielnagar@yahoo.com'}, {'name': 'Gihan el nagar, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maha Taymour, Ass. Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cairo university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'rasmia salem, msc', 'role': 'CONTACT', 'email': 'rasmia.salem@yahoo.com', 'phone': '01024340442'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Rasmia Mamdouh Ali Salem', 'investigatorAffiliation': 'Cairo University'}}}}