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One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers

Primary Purpose

Discoloration, Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lava ultimate
E.max cad
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discoloration, Tooth

Eligibility Criteria

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

Inclusion Criteria:

  1. From 18-50 years old, be able to read and sign the informed consent document.
  2. Be physically and psychologically able to tolerate conventional restorative procedures.
  3. Have no active periodontal or pulpal diseases, have teeth with good restorations.
  4. Patients with teeth problems indicated for laminate veneer (e.g. discoloration, defect not involve more than 60% enamel loss, mild malposition, anterior upper….).
  5. Be willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

  1. Patients in the growth stage with partially erupted teeth.
  2. Patient with fractured teeth of more than 60% enamel loss.
  3. Patients with poor oral hygiene and motivation.
  4. Pregnant women.
  5. Psychiatric problems or unrealistic expectations.
  6. 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

    lava ultimate

    E.max cad

    Arm Description

    lava ultimate is Resin nano-ceramic which is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation.

    E.max is lithium disilicate glass ceramic, composed of quartz, lithium dioxide, phosphor oxide, alumina oxide, and potassium oxide with superior mechanical and optical properties if used for laminate veneers

    Outcomes

    Primary Outcome Measures

    Patient satisfaction evaluated by using a questionnaire
    Patient satisfaction will be evaluated by using a questionnaire, which will be translated. A validation of the Arabic translation will be done before using the questionnaire in the trial. Each participant will take the questionnaire into a quiet room and will be left alone until questionnaire is totally answered.

    Secondary Outcome Measures

    Modified USPHS criteria
    It is a criteria for clinical evaluation of dental restorative materials in terms of marginal adaptation, marginal discoloration, fracture, debonding.

    Full Information

    First Posted
    March 9, 2017
    Last Updated
    March 16, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03086928
    Brief Title
    One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers
    Official Title
    One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers With Butt Joint Preparation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2017 (Anticipated)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    April 2018 (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
    Restoration of anterior teeth using conservative approach allows clinicians to provide porcelain laminate veneers with excellent esthetics without extensive tooth structure removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and hybrid ceramics (Lava Ultimate). The aim of this study is to compare both e.max and lava ultimate veneers clinically.
    Detailed Description
    The use of E-max CAD well documented in the literatures as successful restoration modality which has superior optical and mechanical properties. The introduction of hybrid ceramic materials combined the advantages of both glass ceramics and composite resin. Resin nano-ceramic is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation. Yet there are no studies for clinical evaluation of both mentioned laminate veneers restorations. This study is conducted to compare between both materials clinically according to modified USPHS criteria in terms of marginal adaptation, fracture, debonding, marginal discoloration and patient satisfaction.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    lava ultimate
    Arm Type
    Experimental
    Arm Description
    lava ultimate is Resin nano-ceramic which is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation.
    Arm Title
    E.max cad
    Arm Type
    Active Comparator
    Arm Description
    E.max is lithium disilicate glass ceramic, composed of quartz, lithium dioxide, phosphor oxide, alumina oxide, and potassium oxide with superior mechanical and optical properties if used for laminate veneers
    Intervention Type
    Other
    Intervention Name(s)
    lava ultimate
    Intervention Description
    resin nano ceramic material
    Intervention Type
    Other
    Intervention Name(s)
    E.max cad
    Intervention Description
    Lithium disilicate glass ceramic
    Primary Outcome Measure Information:
    Title
    Patient satisfaction evaluated by using a questionnaire
    Description
    Patient satisfaction will be evaluated by using a questionnaire, which will be translated. A validation of the Arabic translation will be done before using the questionnaire in the trial. Each participant will take the questionnaire into a quiet room and will be left alone until questionnaire is totally answered.
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Modified USPHS criteria
    Description
    It is a criteria for clinical evaluation of dental restorative materials in terms of marginal adaptation, marginal discoloration, fracture, debonding.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: From 18-50 years old, be able to read and sign the informed consent document. Be 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, defect not involve more than 60% enamel loss, mild malposition, anterior upper….). Be 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 60% 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mai elgendi, B.D.S
    Phone
    201126811001
    Email
    mai.eltohami@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    kareem abo bakr, PHD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    amina zaki, PHD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26633080
    Citation
    Pimentel W, Teixeira ML, Costa PP, Jorge MZ, Tiossi R. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report. J Prosthodont. 2016 Jun;25(4):335-40. doi: 10.1111/jopr.12413. Epub 2015 Dec 3.
    Results Reference
    background
    PubMed Identifier
    21773711
    Citation
    D'Arcangelo C, De Angelis F, Vadini M, D'Amario M. Clinical evaluation on porcelain laminate veneers bonded with light-cured composite: results up to 7 years. Clin Oral Investig. 2012 Aug;16(4):1071-9. doi: 10.1007/s00784-011-0593-0. Epub 2011 Jul 20.
    Results Reference
    background

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    One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers

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