CClinicalTrials.gg
Status unknownNCT03621163Updated Aug 8, 2018

Copmere Between Bleaching and Laminate Veneers

An interventional study of Bleaching agent ( BOOST 40%) and laminate veneers(lithium-silicate) in Discoloration, Tooth, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Discoloration, Tooth

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Keywords

  • bleaching agent
03

In context

Tooth Discoloration

102 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's planned enrollment of 1 is below the median of 48 across 95 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1 participant (estimated)

Study arms

  • Experimental
    bleaching agent

    intervention : bleaching agent ( Boost 40%)

    Procedure: Bleaching agent ( BOOST 40%)

  • Active comparator
    laminate veneers

    laminate veneers ( monolithic lithium - silicate)

    Procedure: laminate veneers(lithium-silicate)

Interventions

  • ProcedureBleaching 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.

  • Procedurelaminate 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.

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What researchers measure

Primary outcomes

  1. Color change.

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

    Time frame: 1-4 weeks

Secondary outcomes

  1. Corresponding color with comparator.

    by Digital photographs

    Time frame: 1-4 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 24720860 ↗
  • 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. PubMed 15645893 ↗
  • 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. PubMed 22408775 ↗
  • 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. PubMed 2130332 ↗
  • 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. PubMed 18335728 ↗
  • 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. PubMed 20098962 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03621163
Lead sponsor
Cairo University
Responsible party
Hazim sherif ahmed (Dentist, Cairo University) — Principal investigator
First posted
Aug 8, 2018
Start date
Dec 5, 2018 (estimated)
Primary completion
Sep 5, 2019 (estimated)
Completion
Dec 20, 2019 (estimated)
Last update
Aug 8, 2018

Study contacts

hazim sharif, MSc
Contact
hazimsharif15@gmail.com
00201127260517
omima el mahallwi, prof
Contact
oelmahallawi@dentistry.cu.edu.eg
00201222154399

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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