Copmere Between Bleaching and Laminate Veneers
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|ClinicalTrials.gov Identifier: NCT03621163|
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Discoloration, Tooth||Procedure: Bleaching agent ( BOOST 40%) Procedure: laminate veneers(lithium-silicate)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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:||Single (Outcomes Assessor)|
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.
|Official Title:||Shade Evaluation for Clinical Color Change of Discolored Teeth Treated by Bleaching vs Laminate Veneers.|
|Estimated Study Start Date :||December 5, 2018|
|Estimated Primary Completion Date :||September 5, 2019|
|Estimated Study Completion Date :||December 20, 2019|
Experimental: bleaching agent
intervention : bleaching agent ( Boost 40%)
Procedure: Bleaching agent ( BOOST 40%)
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.
Active Comparator: laminate veneers
laminate veneers ( monolithic lithium - silicate)
Procedure: laminate veneers(lithium-silicate)
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.
- Color change. [ Time Frame: 1-4 weeks ]measures the change of color before and after intervention by Easy Shade Spectrophotometry
- Corresponding color with comparator. [ Time Frame: 1-4 weeks ]by Digital photographs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621163
|Contact: hazim sharif, MScemail@example.com|
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