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Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers

Primary Purpose

Tooth Discoloration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vita suprinity
Emax CAD
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All subjects are required to be:

  • From 18-60 years old, and 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 with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
  • Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

  • Patients in the growth stage with partially erupted teeth
  • Patient with fractured teeth of more than 50% enamel loss
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vita suprinity

    Emax cad

    Arm Description

    Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS).

    lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners

    Outcomes

    Primary Outcome Measures

    Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
    clinical evaluation of Fracture resistance

    Secondary Outcome Measures

    Patient satisfaction assessed using a Questionnaire
    Questionnaire for patient satisfaction

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    July 18, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02940717
    Brief Title
    Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
    Official Title
    Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Vita suprinity
    Arm Type
    Experimental
    Arm Description
    Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS).
    Arm Title
    Emax cad
    Arm Type
    Active Comparator
    Arm Description
    lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners
    Intervention Type
    Other
    Intervention Name(s)
    Vita suprinity
    Other Intervention Name(s)
    zirconia-reinforced lithium silicate ceramic
    Intervention Description
    New glass ceramic material
    Intervention Type
    Other
    Intervention Name(s)
    Emax CAD
    Other Intervention Name(s)
    lithium disilicate glass ceramic
    Intervention Description
    standard etchable glass ceramic used for laminate venneers
    Primary Outcome Measure Information:
    Title
    Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
    Description
    clinical evaluation of Fracture resistance
    Time Frame
    1 Year
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction assessed using a Questionnaire
    Description
    Questionnaire for patient satisfaction
    Time Frame
    1 Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All subjects are required to be: From 18-60 years old, and 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 with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….) Willing to return for follow-up examinations and evaluation Exclusion Criteria: Patients in the growth stage with partially erupted teeth Patient with fractured teeth of more than 50% enamel loss 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27087687
    Citation
    Elsaka SE, Elnaghy AM. Mechanical properties of zirconia reinforced lithium silicate glass-ceramic. Dent Mater. 2016 Jul;32(7):908-14. doi: 10.1016/j.dental.2016.03.013. Epub 2016 Apr 14.
    Results Reference
    background
    PubMed Identifier
    22821429
    Citation
    Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
    Results Reference
    background
    PubMed Identifier
    27004277
    Citation
    Weyhrauch M, Igiel C, Scheller H, Weibrich G, Lehmann KM. Fracture Strength of Monolithic All-Ceramic Crowns on Titanium Implant Abutments. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):304-9. doi: 10.11607/jomi.4601.
    Results Reference
    background

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    Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers

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