Copmere Between Bleaching and Laminate Veneers

NCT ID: NCT03621163

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2019-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Discoloration, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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).

Study Groups

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bleaching agent

intervention : bleaching agent ( Boost 40%)

Group Type EXPERIMENTAL

Bleaching agent ( BOOST 40%)

Intervention Type 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.

laminate veneers

laminate veneers ( monolithic lithium - silicate)

Group Type ACTIVE_COMPARATOR

laminate veneers(lithium-silicate)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hazim sherif ahmed

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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hazim sharif, MSc

Role: CONTACT

00201127260517

omima el mahallwi, prof

Role: CONTACT

00201222154399

References

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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.

Reference Type BACKGROUND
PMID: 24720860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15645893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22408775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2130332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18335728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20098962 (View on PubMed)

Other Identifiers

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DTB&V

Identifier Type: -

Identifier Source: org_study_id

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