Clinical trial NCT03621163: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Discoloration, Tooth
Keywords: bleaching agent
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Color change.
timeFrame: 1-4 weeks
Secondary outcomes:
measure: Corresponding color with comparator.
timeFrame: 1-4 weeks
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.