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