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Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers

Primary Purpose

Teeth Sensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gull wing preparation of laminates veneers
conventional preparation of laminates veneers
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Teeth Sensitivity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • From 18-40 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, fracture not involve more than 50% enamel loss, mild malposition.
  • 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 50% enamel loss.
  • Patients with poor oral hygiene and motivation.
  • Pregnant women.
  • Patient with post and core endodontically treated teeth.
  • 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

    Active Comparator

    Active Comparator

    Arm Label

    gull wing preparation veneers

    conventional preparation veneers

    Arm Description

    intervention: gull wing preparation in laminates veneers proximal margin of the preparation is placed toward the lingual .The area of the proximal margin between the contact area and the gingival papilla is placed even further to the lingual. This preparation design helps to hide the margin when the restorations are viewed from an angle.

    intervention: conventional preparation in laminates veneers preparation of veneers without lingual extension of preparation in mesial and distal areas

    Outcomes

    Primary Outcome Measures

    measuring marginal adaptation of laminates veneers using stero-microscope
    marginal adaptation of laminates veneers will be assess as follows, before laminates cementation, an impression material will be placed in the fitting surface of the veneers and placed over the reduced tooth using finger pressure, after material set the impression replica is separated from the laminates and the replica is section and measures under stero-microscope for marginal adaptation, measurement will be performed in eight different points on the buccal and mesio-distal sections, measurement will be in micrometer.

    Secondary Outcome Measures

    measuring tooth sensitivity after tooth preparation for laminates veneers
    measurment will be acording tomodified United States Public Health Service (USPHS) criteria used for the clinical evaluations of the restorations. post-operative sensitivity 0 No symptoms Slight sensitivity Moderate sensitivity Severe pain

    Full Information

    First Posted
    July 3, 2017
    Last Updated
    July 9, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03214549
    Brief Title
    Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers
    Official Title
    Marginal Adaptation of E.Max Laminate Veneers Prepared With Modified Gull Wing Preparation and Conventional Preparation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 13, 2018 (Anticipated)
    Primary Completion Date
    October 1, 2018 (Anticipated)
    Study Completion Date
    October 1, 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
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain laminates veneers prepared with modified gull wing preparation and conventional preparation.
    Detailed Description
    Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radio-graphic examination and primary impression for diagnostic cast construction. Visit 2: Teeth preparation, secondary impression,temporary restoration and teeth sensitivity evaluation using United States Public Health Service criteria. Visit 3: Placement and permanent cementation of the final restoration Visit 4: marginal adaptation measurement by electron microscope using impression replica.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Teeth Sensitivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gull wing preparation veneers
    Arm Type
    Active Comparator
    Arm Description
    intervention: gull wing preparation in laminates veneers proximal margin of the preparation is placed toward the lingual .The area of the proximal margin between the contact area and the gingival papilla is placed even further to the lingual. This preparation design helps to hide the margin when the restorations are viewed from an angle.
    Arm Title
    conventional preparation veneers
    Arm Type
    Active Comparator
    Arm Description
    intervention: conventional preparation in laminates veneers preparation of veneers without lingual extension of preparation in mesial and distal areas
    Intervention Type
    Procedure
    Intervention Name(s)
    gull wing preparation of laminates veneers
    Other Intervention Name(s)
    dog leg preparation of laminates veneers
    Intervention Description
    preparation involving mesial and distal extension further lingualy.
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional preparation of laminates veneers
    Intervention Description
    preparation not involving mesial and distal extension further lingualy.
    Primary Outcome Measure Information:
    Title
    measuring marginal adaptation of laminates veneers using stero-microscope
    Description
    marginal adaptation of laminates veneers will be assess as follows, before laminates cementation, an impression material will be placed in the fitting surface of the veneers and placed over the reduced tooth using finger pressure, after material set the impression replica is separated from the laminates and the replica is section and measures under stero-microscope for marginal adaptation, measurement will be performed in eight different points on the buccal and mesio-distal sections, measurement will be in micrometer.
    Time Frame
    immediately before laminates delivery up to 4 week sfter tooth preparation
    Secondary Outcome Measure Information:
    Title
    measuring tooth sensitivity after tooth preparation for laminates veneers
    Description
    measurment will be acording tomodified United States Public Health Service (USPHS) criteria used for the clinical evaluations of the restorations. post-operative sensitivity 0 No symptoms Slight sensitivity Moderate sensitivity Severe pain
    Time Frame
    one week after tooth preparation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: From 18-40 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, fracture not involve more than 50% enamel loss, mild malposition. 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 50% enamel loss. Patients with poor oral hygiene and motivation. Pregnant women. Patient with post and core endodontically treated teeth. 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
    housham N Musa, master
    Phone
    00201068778033
    Email
    dr_hishamnabeel@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    rayan R dahab, master
    Phone
    00201068775688
    Email
    rayanrabiedahab@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers

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