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Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement

Primary Purpose

Tooth Discoloration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement
E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement
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

    dual cure amine free adhesive resin cement

    light cured adhesive resin cement

    Arm Description

    resin cement that get activated by both light and chemicals

    resin cement that only get activated by light

    Outcomes

    Primary Outcome Measures

    Color stability assessed clinically using easy shade vita device
    Color stability

    Secondary Outcome Measures

    Patient satisfaction assessed using a Questionnaire
    Questionnaire for the patient satisfaction

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    October 21, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02943395
    Brief Title
    Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time. A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in 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
    dual cure amine free adhesive resin cement
    Arm Type
    Experimental
    Arm Description
    resin cement that get activated by both light and chemicals
    Arm Title
    light cured adhesive resin cement
    Arm Type
    Active Comparator
    Arm Description
    resin cement that only get activated by light
    Intervention Type
    Other
    Intervention Name(s)
    E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement
    Intervention Type
    Other
    Intervention Name(s)
    E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement
    Primary Outcome Measure Information:
    Title
    Color stability assessed clinically using easy shade vita device
    Description
    Color stability
    Time Frame
    1 Year
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction assessed using a Questionnaire
    Description
    Questionnaire for the 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud Elkomy, B.D.s
    Phone
    01113735370
    Email
    mahmoud.hossam919@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jylan elguindy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24118675
    Citation
    Magalhaes AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7.
    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

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    Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement

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