Copmere Between Bleaching and Laminate Veneers

NCT03621163 | Unknown

• 1 other identifier: DTB&V
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Discoloration, Tooth

Keywords

bleaching agent

Outcome Measures

Primary Outcomes (1)

• Color change.

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

  1-4 weeks

Secondary Outcomes (1)

• Corresponding color with comparator.

  1-4 weeks

Study Arms (2)

bleaching agent

EXPERIMENTAL

intervention : bleaching agent ( Boost 40%)

Procedure: Bleaching agent ( BOOST 40%)

laminate veneers

ACTIVE COMPARATOR

laminate veneers ( monolithic lithium - silicate)

Procedure: laminate veneers(lithium-silicate)

Interventions

Bleaching agent ( BOOST 40%) PROCEDURE

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.

bleaching agent

laminate veneers(lithium-silicate) PROCEDURE

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.

laminate veneers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (6)

• 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.

  PMID: 24720860 BACKGROUND

• 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.

  PMID: 15645893 BACKGROUND

• 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.

  PMID: 22408775 BACKGROUND

• 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.

  PMID: 2130332 BACKGROUND

• 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.

  PMID: 18335728 BACKGROUND

• 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.

  PMID: 20098962 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Bleaching Agents

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oxidants; Specialty Uses of Chemicals; Chemical Actions and Uses

Central Study Contacts

hazim sharif, MSc

CONTACT

00201127260517; hazimsharif15@gmail.com

omima el mahallwi, prof

CONTACT

00201222154399; oelmahallawi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 8, 2018
• Study Start: December 5, 2018
• Primary Completion: September 5, 2019
• Study Completion: December 20, 2019
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share