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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 29, 2021
    Last Updated
    June 3, 2021
    Sponsor
    Cairo University
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    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
    background

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    Wear of Enamel Antagonist to ZLS Crowns

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