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Clinical Assessement of Glazed Versus Polished Lithium Disilicate Crowns in Surface Roughness and Enamel Antagonists Wear

Primary Purpose

Tooth Decay

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polished emax Press
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Decay

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients from 18-50 years old who are able to read and sign the informed consent document.
  • Physically and psychologically able to tolerate conventional restorative procedures.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Patients have no temporomandibular disorders.
  • Each participant needed a crown on either a first or second premolar or first or second molar in any arch.
  • Teeth selected shoud include:

restorability with a crown:root ratio of at least 1:1. presence of an opposing natural tooth which was non-restored or minimally restored.

the presence of two non-restored or minimally restored teeth opposing each other on the same quadrants as the crowned tooth and the opposing to serve as enamel controls. Minimally restored was defined as teeth which have no restoration greater than a Class II amalgam restoration.

- Willing to return for follow-up examinations and evaluation.

Exclusion criteria

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene and motivation.
  • Pregnant women.
  • Psychiatric problems or unrealistic expectations.
  • Lack of opposite occluding dentition in the area intended for restoration.
  • Patients with temporomandibular disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    glazed emax Press

    Polished emax Press

    Arm Description

    Outcomes

    Primary Outcome Measures

    Antagonists enamel wear using profilometer
    wear of enamel antagonists opposing to emaxPress crowns that will be measured in um

    Secondary Outcome Measures

    Restoration surface Roughness using profilometer
    restoration roughness after different finishing methods that will me measured in um
    Patient satisfaction
    Questionnaire

    Full Information

    First Posted
    October 2, 2018
    Last Updated
    October 3, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03696849
    Brief Title
    Clinical Assessement of Glazed Versus Polished Lithium Disilicate Crowns in Surface Roughness and Enamel Antagonists Wear
    Official Title
    Patient Satisfaction and Clinical Assessment of Surface Roughness and Wear of Enamel Antagonists for Polished Versus Glazed Posterior Lithium Disilicate Glass Ceramic Crowns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2018 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    January 2020 (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
    No

    5. Study Description

    Brief Summary
    It is believed that final glazing yields the most acceptable ceramic surfaces in terms of smoothness. However, since reglazing must be performed in a dental laboratory with the use of a thermal furnace, it requires multiple office visits. Repeated firings have a destructive effect on ceramic surfaces and can cause deformation. Conversely, polishing is easy and simple and can be accomplished in a single session.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Decay

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    glazed emax Press
    Arm Type
    Active Comparator
    Arm Title
    Polished emax Press
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    polished emax Press
    Other Intervention Name(s)
    emaxPressable ceramics
    Intervention Description
    lithium disilicate glass ceramic crowns subjected to polishing only
    Primary Outcome Measure Information:
    Title
    Antagonists enamel wear using profilometer
    Description
    wear of enamel antagonists opposing to emaxPress crowns that will be measured in um
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Restoration surface Roughness using profilometer
    Description
    restoration roughness after different finishing methods that will me measured in um
    Time Frame
    1 year
    Title
    Patient satisfaction
    Description
    Questionnaire
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients from 18-50 years old who are able to read and sign the informed consent document. Physically and psychologically able to tolerate conventional restorative procedures. Have no active periodontal or pulpal diseases, have teeth with good restorations. Patients have no temporomandibular disorders. Each participant needed a crown on either a first or second premolar or first or second molar in any arch. Teeth selected shoud include: restorability with a crown:root ratio of at least 1:1. presence of an opposing natural tooth which was non-restored or minimally restored. the presence of two non-restored or minimally restored teeth opposing each other on the same quadrants as the crowned tooth and the opposing to serve as enamel controls. Minimally restored was defined as teeth which have no restoration greater than a Class II amalgam restoration. - Willing to return for follow-up examinations and evaluation. Exclusion criteria Patients in the growth stage with partially erupted teeth. Patients with poor oral hygiene and motivation. Pregnant women. Psychiatric problems or unrealistic expectations. Lack of opposite occluding dentition in the area intended for restoration. Patients with temporomandibular disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mervat Rouchdy, M.D.s
    Phone
    01272625020
    Email
    mervatmourad82@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lamia Khair Allah

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Assessement of Glazed Versus Polished Lithium Disilicate Crowns in Surface Roughness and Enamel Antagonists Wear

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