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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03621163
Other study ID # DTB&V
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 5, 2018
Est. completion date December 20, 2019

Study information

Verified date August 2018
Source Cairo University
Contact hazim sharif, MSc
Phone 00201127260517
Email hazimsharif15@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study is aimed to evaluation of shade for clinical color change of discolored teeth treated by bleaching vs laminate veneers.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date December 20, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (6)

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. — View 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. — View 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. — View 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):396-9. doi: 10.1111/edt.12109. Epub 2014 Apr 10. — View Citation

Marson FC, Sensi LG, Vieira LC, Araújo 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Color change. measures the change of color before and after intervention by Easy Shade Spectrophotometry 1-4 weeks
Secondary Corresponding color with comparator. by Digital photographs 1-4 weeks
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