search
Back to results

Copmere Between Bleaching and Laminate Veneers

Primary Purpose

Discoloration, Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bleaching agent ( BOOST 40%)
laminate veneers(lithium-silicate)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discoloration, Tooth focused on measuring bleaching agent

Eligibility Criteria

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

Inclusion Criteria:

  • Patients included in this clinical trial :

    • Men and women between 15and 40 years of age.
    • Had good general and oral health.
    • The participants needed to have six vital maxillary or mandibular anterior teeth without caries lesions or restorations.
    • The maxillary canine was shade A3 or darker as judged by comparison with a shade guide (VITA Classical Shade Guide or Spectrophotometer measurement ).

Exclusion Criteria:

  • Participants were excluded from the study

    • If they presented with anterior restorations; had bruxism habits.
    • Were pregnant/lactating; presented with non vital tooth discoloration.
    • were taking any drug with anti-inflammatory, analgesic, or antioxidant effect; or presented with recession and dentin exposure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    bleaching agent

    laminate veneers

    Arm Description

    intervention : bleaching agent ( Boost 40%)

    laminate veneers ( monolithic lithium - silicate)

    Outcomes

    Primary Outcome Measures

    Color change.
    measures the change of color before and after intervention by Easy Shade Spectrophotometry

    Secondary Outcome Measures

    Corresponding color with comparator.
    by Digital photographs

    Full Information

    First Posted
    July 29, 2018
    Last Updated
    August 7, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03621163
    Brief Title
    Copmere Between Bleaching and Laminate Veneers
    Official Title
    Shade Evaluation for Clinical Color Change of Discolored Teeth Treated by Bleaching vs Laminate Veneers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 5, 2018 (Anticipated)
    Primary Completion Date
    September 5, 2019 (Anticipated)
    Study Completion Date
    December 20, 2019 (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

    5. Study Description

    Brief Summary
    The present study is aimed to evaluation of shade for clinical color change of discolored teeth treated by bleaching vs laminate veneers.
    Detailed Description
    Dental aesthetics, including tooth color, is of great importance for majority of the people and any discoloration or staining can affect their quality of life negatively1,2. In the UK it has been reported that 28% of grownups are dissatisfied with the appearance of their teeth and in the USA that 34% of grownups population are dissatisfied with their current tooth color. Moreover, in a survey of 3215 subjects from the UK 50% have admitted that they had some kind of tooth discoloration3,4. Tooth bleaching has become one of the most popular aesthetic dental treatments. Because tooth bleaching is an effective, non-invasive procedure for the change of tooth discoloration, it is the best of treatment options for improving teeth color 5. Ceramic restorations with excellent biocompatibility are widely used to achieve highly aesthetic characteristics in fixed prosthodontics6. Porcelain laminate veneers have become a popular method of treated tooth discoloration. But are expensive, brittle and difficult to repair7.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    split mouth randomized control, co-supervisor will write number for each member in each group (left side treatment A, right side treatment B or left side treatment B, right side treatment A) by indispensible pen on large white paper sheet. The sheet will be folded eight times and saved inside opaque well sealed envelope in which the inner content cannot be seen by naked eyes.
    Masking
    Outcomes Assessor
    Masking Description
    Single blinded (outcome assessor). Assessors supervisor and co-supervisor will be blinded to the assigned material. However the operator and patient can't be blinded due to the difference in preparation and shade of the ceramic materials and bleaching agent. The assessors will assess all outcomes blinded to the material assigned for each patient. Three spectrophotometer measurements will be recorded each time, with the active point of the instrument focused on the cervical third of each tooth, then mean color from three measurements will be calculated. Digital photograph measures the color of teeth based on the Adobe Photoshop software. (Version 5.5).
    Allocation
    Randomized
    Enrollment
    1 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    bleaching agent
    Arm Type
    Experimental
    Arm Description
    intervention : bleaching agent ( Boost 40%)
    Arm Title
    laminate veneers
    Arm Type
    Active Comparator
    Arm Description
    laminate veneers ( monolithic lithium - silicate)
    Intervention Type
    Procedure
    Intervention Name(s)
    Bleaching agent ( BOOST 40%)
    Intervention Description
    Opalescence Boost 40% is a 40% hydrogen peroxide, medical power bleaching gel. The jet mix syringe ensures freshness for each application and precise dosing of the activator. One barrel contains a unique chemical activation with sodium fluoride and potassium nitrate, which have been demonstrated to reduce caries susceptibility, lower sensitivity, and improve enamel micro-hardness. The other barrel contains the concentrated hydrogen peroxide. When mixed, Opalescence Boost results in a 1.1% fluoride and 3% potassium nitrate concentration.
    Intervention Type
    Procedure
    Intervention Name(s)
    laminate veneers(lithium-silicate)
    Intervention Description
    A lithium-silicate glass ceramic is newly introduced to the market. After crystallization, it demonstrates an ideal combination of strength, aesthetics and translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns. It differentiated from other ceramics by its high chipping resistance, due to their monolithic composition and average flexural strength of 385 MPa. Also Milling Block has good wear resistance due to the high content of ultra-fine nano-meter size crystalline structure. Lithium-silicates ceramic blocks are available in the commonly used VITA Classical and Chromascop Bleach shades.
    Primary Outcome Measure Information:
    Title
    Color change.
    Description
    measures the change of color before and after intervention by Easy Shade Spectrophotometry
    Time Frame
    1-4 weeks
    Secondary Outcome Measure Information:
    Title
    Corresponding color with comparator.
    Description
    by Digital photographs
    Time Frame
    1-4 weeks

    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: Patients included in this clinical trial : Men and women between 15and 40 years of age. Had good general and oral health. The participants needed to have six vital maxillary or mandibular anterior teeth without caries lesions or restorations. The maxillary canine was shade A3 or darker as judged by comparison with a shade guide (VITA Classical Shade Guide or Spectrophotometer measurement ). Exclusion Criteria: Participants were excluded from the study If they presented with anterior restorations; had bruxism habits. Were pregnant/lactating; presented with non vital tooth discoloration. were taking any drug with anti-inflammatory, analgesic, or antioxidant effect; or presented with recession and dentin exposure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hazim sharif, MSc
    Phone
    00201127260517
    Email
    hazimsharif15@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    omima el mahallwi, prof
    Phone
    00201222154399
    Email
    oelmahallawi@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24720860
    Citation
    Gupta SK, Saxena P. Evaluation of patient satisfaction after non-vital bleaching in traumatized discolored intact anterior teeth. Dent Traumatol. 2014 Oct;30(5):396-399. doi: 10.1111/edt.12109. Epub 2014 Apr 10.
    Results Reference
    background
    PubMed Identifier
    15645893
    Citation
    Gerlach RW, Zhou X. Clinical trial comparing two daytime hydrogen-peroxide professional vital-bleaching systems. Compend Contin Educ Dent. 2004 Aug;25(8 Suppl 2):33-40.
    Results Reference
    background
    PubMed Identifier
    22408775
    Citation
    Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9.
    Results Reference
    background
    PubMed Identifier
    2130332
    Citation
    Mountouris G, Mantzavinos Z, Michou H. [Discolorations: a new method of bleaching discolored vital teeth. (Preliminary study)]. Odontostomatol Proodos. 1990 Jun;44(3):195-206. Greek, Modern.
    Results Reference
    background
    PubMed Identifier
    18335728
    Citation
    Marson FC, Sensi LG, Vieira LC, Araujo E. Clinical evaluation of in-office dental bleaching treatments with and without the use of light-activation sources. Oper Dent. 2008 Jan-Feb;33(1):15-22. doi: 10.2341/07-57.
    Results Reference
    background
    PubMed Identifier
    20098962
    Citation
    Alomari Q, El Daraa E. A randomized clinical trial of in-office dental bleaching with or without light activation. J Contemp Dent Pract. 2010 Jan 1;11(1):E017-24.
    Results Reference
    background

    Learn more about this trial

    Copmere Between Bleaching and Laminate Veneers

    We'll reach out to this number within 24 hrs