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Clinical Evaluation of Fracture Resistance and Color Changes of Laminate Veneer With Gull Wing Preparation

Primary Purpose

Discolored Teeth

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

About this trial

This is an interventional treatment trial for Discolored Teeth

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers
  • Inclusion Criteria
  • age groups from 18-50-year-old
  • patients able to read and sign the informed consent.
  • patient without periodontal diseases
  • Patients indicated for laminate veneers.
  • patients Willing to return for follow -up
  • Exclusion Criteria
  • Patients with poor oral hygiene
  • patients with endodontic ally treated teeth
  • patients with Psychiatric problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    modified gull wing preparation

    conventional preparation

    Arm Description

    Gullwing preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation

    In conventional preparation of veneer it circumvents the contact areas and extends palatally in the incisal third of the tooth only. The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines placed facially to the proximal contacts Gull wing (dog leg) preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. This preparation design helps to hide the restoration margin when viewed from an angle, especially in discoloration. The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.

    Outcomes

    Primary Outcome Measures

    fracture of restoration
    The fracture of the restoration of the two groups will be assessed using the modified United States public health service ( USPHS) criteria

    Secondary Outcome Measures

    color changed
    Secondary outcome : Color match Color changes of the two groups will be assessed using the modified United States public health service (USPHS) criteria

    Full Information

    First Posted
    October 21, 2017
    Last Updated
    March 25, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03321474
    Brief Title
    Clinical Evaluation of Fracture Resistance and Color Changes of Laminate Veneer With Gull Wing Preparation
    Official Title
    Clinical Evaluation of Fracture Resistance and Color Changes of All Ceramic Laminate Veneers Prepared With Modified Gull Wing Versus Conventional Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    May 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
    Yes

    5. Study Description

    Brief Summary
    Patient with discolored anterior teeth and need conservative restoration treated with all ceramic esthetic laminate veneers. The Patient will be satisfied with restoration mimic the surrounding natural teeth, but conventional preparation shows approximately 60% of veneer failure in form of color change and nearly 67% Fractures of laminate veneers so the modified gull wing preparation is a significant factor affecting the final esthetic especially in discolored teeth and improve fracture resistance of the restoration.
    Detailed Description
    This trial will be conducted on patient from the outpatient clinic in the fixed prosthodontics clinic, faculty of oral and dental medicine, Cairo University Adherence session will take place in the presence of the patients in the initial visit. This include that patient will be informed by Z Elshamy about the study steps and maintenance of oral hygiene instructions. Participants will be asked by Z Elshamy if they have any problems. Motivation and enforcing the maintenance of oral hygiene measures by ZElshamy. The visits will be designated as follow: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic examination, intraoral photographs, and primary impression for diagnostic cast construction. Visit 2: teeth preparation, secondary impression using addition silicone rubber base material and temporary restoration. Visit 3: one week after the second visit, try in for the restoration will be done. Visit 4: placement and permanent cementation of the final restoration. Visit 5: Every 2 months post operatively follow-up visit for one year. Sample size: Since no previously published effect size data regarding the effectiveness of neither the intervention nor the control exist, an estimated sample of (20 restorations) would be used with allocation ratio 1:1 Recruitment: The patients fulfilled the inclusion criteria will be selected from the outpatient clinic of the fixed prosthodontics department - Cairo University. Screening of patients will be carried out until the target population is reached. Methods: Assignment of interventions (for controlled trial) Sequence generation. The participant teeth will be allocated into two groups with 1:1 allocation ratio by using computerized Sequence generation. Plans to promote participant retention &complete follow up : Telephone numbers and address of the patient included in the study will be Recorded. All patients will be given a phone call before the next appointment. Data management: All data will be entered electronically. Patient files are to be stored in Numerical order in a secured place. This will be carried out by ZElshamy Statistical methods Data analysis All Data will be collected, checked, revised, tabulated and entered into the computer by ZElshamy. Quantitative variables from the normal distribution will be expressed as mean and standard deviation (SD) values. To test the significant differences between two groups at different follow-up period's student t-test will be used. Significant level will be set at P ≤ 0.05 Statistical analysis will be done using Statistical Package for Social Sciences, Version 21.0 (SPSS, IBM, Chicago, III, USA) for Windows. Data monitoring: The main supervisor is responsible for data monitoring if harms arise, an interim analysis will be done. (El Mahallawi O). Harms: Any adverse effect of pain or even failure will be recorded, documented and treated. Consent: Researcher will discuss the trial with all patients. Patients will then be able to have an informed discussion with the researcher. A researcher will obtain written consent from patients willing to participate in the trial. All consent forms will be in the Arabic language Confidentiality :All study-related information will be stored securely. All participants' information will be stored in locked file cabinets in areas with limited access. All data collection, process, and administrative forms will be identified by a coded ID [identification] number only to maintain participant confidentiality. All records that contain names or other personal identifiers will be stored separately from study records identified by code number. All local databases will be secured with password-protected access systems. Access to data :The investigator and supervisors will be given access to the data sets. All data sets will be password protected. To ensure confidentiality, Participant study information will become confidentially Ancillary and post-trial care :All patients will be followed up until complete period study& patients' satisfactions occur. As any prosthetic treatment post insertion adjustment is necessary and in this trial recalls maintenance. Dissemination policy : Study results will be published as partial fulfillment of the requirements for PHD degree in fixed prosthodontics. - Topics suggested for presentation or publication will be circulated to the authors. Data collection methods: Primary outcome: The fracture of the restoration of the two groups will be assessed using the modified United States public health service ( USPHS) criteria Secondary outcome: Color changes of the two groups will be assessed using the modified United States public health service (USPHS) criteria

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    modified gull wing preparation
    Arm Type
    Experimental
    Arm Description
    Gullwing preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation
    Arm Title
    conventional preparation
    Arm Type
    Active Comparator
    Arm Description
    In conventional preparation of veneer it circumvents the contact areas and extends palatally in the incisal third of the tooth only. The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines placed facially to the proximal contacts Gull wing (dog leg) preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. This preparation design helps to hide the restoration margin when viewed from an angle, especially in discoloration. The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.
    Intervention Type
    Procedure
    Intervention Name(s)
    modified gull wing preparation
    Other Intervention Name(s)
    dog leg ,dog-led -proximal extension preparation
    Intervention Description
    preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.
    Primary Outcome Measure Information:
    Title
    fracture of restoration
    Description
    The fracture of the restoration of the two groups will be assessed using the modified United States public health service ( USPHS) criteria
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    color changed
    Description
    Secondary outcome : Color match Color changes of the two groups will be assessed using the modified United States public health service (USPHS) criteria
    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 age groups from 18-50-year-old patients able to read and sign the informed consent. patient without periodontal diseases Patients indicated for laminate veneers. patients Willing to return for follow -up Exclusion Criteria Patients with poor oral hygiene patients with endodontic ally treated teeth patients with Psychiatric problems
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zeinab saeed Elshamy, MDS
    Phone
    01125195692
    Email
    zeinab.alshamy@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Duzyol M, Duzyol E, Seven N. Fracture Resistance of Laminate Veneers Made with Different Cutting and Preparation Techniques. 2016;4(3):42-48. doi:10.12691/ijdsr-4-3-3.
    Results Reference
    background
    PubMed Identifier
    25408598
    Citation
    Alhekeir DF, Al-Sarhan RA, Al Mashaan AF. Porcelain laminate veneers: Clinical survey for evaluation of failure. Saudi Dent J. 2014 Apr;26(2):63-7. doi: 10.1016/j.sdentj.2014.02.003. Epub 2014 Mar 26.
    Results Reference
    background

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    Clinical Evaluation of Fracture Resistance and Color Changes of Laminate Veneer With Gull Wing Preparation

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