- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914962
Wear of Enamel Antagonist to ZLS Crowns (zls)
Wear of Enamel Antagonist to Polished Versus Glazed Zirconia Reinforced Lithium Silicate Crowns (Randomized Clinical Trial)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ibrahim S Rady, Master
- Phone Number: 0201099576840
- Email: ibrahim.rady@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: monolithic glazedcrowns
glazed Celtra due crowns
|
monolithic glazed crown
Other Names:
|
|
EXPERIMENTAL: monolithic polished crowns
polished Celtra due crowns
|
monolithic polishedcrowns
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
antagonist enamel wear
Time Frame: 6 months
|
Intraoral digital scanner and superimposition software Mm3 intraoral scanning of enamel antagonist to determine amount of wear in Mm3 |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eman M Anwer, professor, professor of fixed prosthodontics
- Study Director: karim Abo Bakr Mohamed, PhD, teacher of fixed prosthodontics
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wear & ZLS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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