Discoloration, ToothNCT03621163
Copmere Between Bleaching and Laminate Veneers
A study testing Bleaching agent ( BOOST 40%) and laminate veneers(lithium-silicate) in people with Discoloration, Tooth, run by Cairo University.
Trial summary
The present study is aimed to evaluation of shade for clinical color change of discolored teeth treated by bleaching vs laminate veneers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration, Tooth
- What is being tested?
- Bleaching agent ( BOOST 40%) and laminate veneers(lithium-silicate)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 ).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Shade Evaluation for Clinical Color Change of Discolored Teeth Treated by Bleaching vs Laminate Veneers.
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.
- Conditions
- Discoloration, Tooth
- Being tested
- Bleaching agent ( BOOST 40%), laminate veneers(lithium-silicate)
- Keywords
- bleaching agent
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleaching agent ( BOOST 40%)Procedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| bleaching agent | Experimental | intervention : bleaching agent ( Boost 40%) Receives: Procedure: Bleaching agent ( BOOST 40%) |
| laminate veneers | Active comparator | laminate veneers ( monolithic lithium - silicate) Receives: Procedure: laminate veneers(lithium-silicate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change.
measures the change of color before and after intervention by Easy Shade Spectrophotometry
Measured: 1-4 weeks
Secondary outcomes (1)
Corresponding color with comparator.
by Digital photographs
Measured: 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start5 Dec 2018 (estimated)
- Primary completion5 Sep 2019 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Discoloration, ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazim sherif ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621163
- Sponsor's protocol ID
- DTB&V
- Status last verified
- Aug 2018
- First submitted
- 29 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24720860Gerlach 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 15645893Almeida 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 22408775Mountouris 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 2130332Marson 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 18335728Alomari 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shade Evaluation for Clinical Color Change of Discolored Teeth Treated by Bleaching vs Laminate Veneers.
- ClinicalTrials.gov ID
- NCT03621163
- Acronym / sponsor ID
- DTB&V
- Conditions
- Discoloration, Tooth
- Keywords
- bleaching agent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Dec 2018 (estimated)
- Primary completion
- 5 Sep 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| bleaching agent | Experimental | Procedure: Bleaching agent ( BOOST 40%)intervention : bleaching agent ( Boost 40%) |
| laminate veneers | Active comparator | Procedure: laminate veneers(lithium-silicate)laminate veneers ( monolithic lithium - silicate) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients included in this clinical trial :
Key exclusion criteria (4 listed)
- Participants were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | bleaching agent |
| 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. | Procedure or surgery | laminate veneers |
Primary outcome
Color change.
Time frame: 1-4 weeks
measures the change of color before and after intervention by Easy Shade Spectrophotometry
1 secondary outcome
Corresponding color with comparator.
Time frame: 1-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 24720860Gupta 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.
- Background: PubMed 15645893Gerlach 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.
- Background: PubMed 22408775Almeida 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.
- Background: PubMed 2130332Mountouris 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.
- Background: PubMed 18335728Marson 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.
- Background: PubMed 20098962Alomari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Bleaching agent ( BOOST 40%) and laminate veneers(lithium-silicate) in people with Discoloration, Tooth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hazim sharif, MSc (00201127260517, hazimsharif15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color change. (time frame: 1-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621163, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.