Wear of Enamel Antagonist to ZLS Crowns (zls)
Primary Purpose
Wear, Tooth, Wear, Occlusal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glazed zirconium lithium silicate
polished zirconium lithium silicate
Sponsored by
About this trial
This is an interventional treatment trial for Wear, Tooth focused on measuring ZLS, crowns, occlusal wear, glass ceramic, polished vs glazed
Eligibility Criteria
Inclusion Criteria:
- Pt aged 21-60 years old, be able to read and sign the informed consent document.
- Psychologically and physically able to withstand conventional dental procedures.
- Patients needing posterior full coverage restorations
- Patients with sound natural antagonists.
- Have no active periodontal or pulpal diseases
- Able to attend punctually for preplanned visits and evaluation.
Exclusion Criteria:
- Patients with poor oral hygiene, high caries risk and uncooperative patients.
- Pregnant women.
- Psychiatric problems or unrealistic expectations.
- Lack of opposing dentition in the area of interest.
- Restored occlusal surface opposing the planned restoration.
- The presence of a removable or fixed orthodontic appliance.
- Patients with parafunctional habits.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
monolithic glazedcrowns
monolithic polished crowns
Arm Description
glazed Celtra due crowns
polished Celtra due crowns
Outcomes
Primary Outcome Measures
antagonist enamel wear
Intraoral digital scanner and superimposition software Mm3
intraoral scanning of enamel antagonist to determine amount of wear in Mm3
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04914962
Brief Title
Wear of Enamel Antagonist to ZLS Crowns
Acronym
zls
Official Title
Wear of Enamel Antagonist to Polished Versus Glazed Zirconia Reinforced Lithium Silicate Crowns (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the antagonist enamel wear of two processing options of Celtra duo crowns (polished and glaze fired) restoring posterior teeth in comparison with sound enamel wear at baseline and 6 months
Detailed Description
Adhesive dental ceramics have proven to guarantee optimal esthetic results alongside satisfactory mechanical properties. Due to these qualities, today they are considered the first-choice restorative materials both for minimal restorations and for the reconstruction of severely compromised teeth. Gold alloy reconstructions preferred in the past, especially for their optimal wear properties, have been progressively substituted by these new materials.
Loss of hard tooth substance is a natural process taking place during mastication. Also, Increased wear is a common reason of failure for restorations exposed to masticatory forces. Excessive wear may be responsible for numerous problems, such as hypersensitivity, loss of occlusal contact, defects of the periodontium, reduction of masticatory efficiency, tooth migration and wrong tooth relations, weakness of masticatory muscles, and changes in the vertical and horizontal jaw relations, which may cause functional and esthetic impairments.
An optimal restorative material should provide similar characteristics to natural dental tissues. The physiological wear of enamel and dentin should represent the reference for a reasonable wear pattern of restorative materials The manufacturers tend to improve the mechanical behavior of their products leads to the progressive offer of new ceramics for daily practice. Assessment of their wear behavior and comparison through detailed tests become necessary at this point.
comparing the wear of enamel opposing polished zirconia, polished lithium disilicate crowns opposing to natural tooth. Patients were recalled after 1year and impression were recorded with opposing arch and baseline and final cast were scanned and superimposed using 3 D scanner. They found that the mean of occlusal wear of the antagonistic enamel of polished zirconia was 42.0 μm, Enamel wear against natural antagonist (control group) 34.68 μm, whereas, for Enamel wear against polished lithium disilicate crowns (group 2) 40.06 μm Enamel wear against natural antagonist (control group) 35.09 μm.
studying 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wear, Tooth, Wear, Occlusal
Keywords
ZLS, crowns, occlusal wear, glass ceramic, polished vs glazed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient will receive a restoration with superior function, esthetics, and excellent clinical performance
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
monolithic glazedcrowns
Arm Type
Active Comparator
Arm Description
glazed Celtra due crowns
Arm Title
monolithic polished crowns
Arm Type
Experimental
Arm Description
polished Celtra due crowns
Intervention Type
Other
Intervention Name(s)
glazed zirconium lithium silicate
Other Intervention Name(s)
glazed Celtra due
Intervention Description
monolithic glazed crown
Intervention Type
Other
Intervention Name(s)
polished zirconium lithium silicate
Other Intervention Name(s)
polished Celtra due
Intervention Description
monolithic polishedcrowns
Primary Outcome Measure Information:
Title
antagonist enamel wear
Description
Intraoral digital scanner and superimposition software Mm3
intraoral scanning of enamel antagonist to determine amount of wear in Mm3
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pt aged 21-60 years old, be able to read and sign the informed consent document.
Psychologically and physically able to withstand conventional dental procedures.
Patients needing posterior full coverage restorations
Patients with sound natural antagonists.
Have no active periodontal or pulpal diseases
Able to attend punctually for preplanned visits and evaluation.
Exclusion Criteria:
Patients with poor oral hygiene, high caries risk and uncooperative patients.
Pregnant women.
Psychiatric problems or unrealistic expectations.
Lack of opposing dentition in the area of interest.
Restored occlusal surface opposing the planned restoration.
The presence of a removable or fixed orthodontic appliance.
Patients with parafunctional habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim S Rady, Master
Phone
0201099576840
Email
ibrahim.rady@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman M Anwer, professor
Organizational Affiliation
professor of fixed prosthodontics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
karim Abo Bakr Mohamed, PhD
Organizational Affiliation
teacher of fixed prosthodontics
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
32053459
Citation
De Angelis F, D'Arcangelo C, Maliskova N, Vanini L, Vadini M. Wear Properties of Different Additive Restorative Materials Used for Onlay/Overlay Posterior Restorations. Oper Dent. 2020 May/Jun;45(3):E156-E166. doi: 10.2341/19-115-L. Epub 2020 Feb 13.
Results Reference
background
PubMed Identifier
22240686
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.
Results Reference
background
PubMed Identifier
8279271
Citation
Dahl BL, Carlsson GE, Ekfeldt A. Occlusal wear of teeth and restorative materials. A review of classification, etiology, mechanisms of wear, and some aspects of restorative procedures. Acta Odontol Scand. 1993 Oct;51(5):299-311. doi: 10.3109/00016359309040581.
Results Reference
background
PubMed Identifier
32089603
Citation
Nazirkar GS, Patil SV, Shelke PP, Mahagaonkar P. Comparative evaluation of natural enamel wear against polished yitrium tetragonal zirconia and polished lithium disilicate - An in vivo study. J Indian Prosthodont Soc. 2020 Jan-Mar;20(1):83-89. doi: 10.4103/jips.jips_218_19. Epub 2020 Jan 27.
Results Reference
background
PubMed Identifier
24980739
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.
Results Reference
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Wear of Enamel Antagonist to ZLS Crowns
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