Tooth DiscolorationPhase 4NCT01231243
Clinical Effectiveness of In-office Bleaching Activated With a LED/Laser Device
A Phase 4 study testing in-office bleaching with/without light in people with Tooth Discoloration, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
Trial summary
There is a controversy in the dentistry literature about how the use of associated light to activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the bleaching effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- in-office bleaching with/without light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 4
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants should be at least 18 years old;
- Participants should have good general and oral health
- Participants should have six caries-free maxillary anterior teeth without restorations on the labial surfaces
- Participants should be willing to sign a consent form
- Participants should have central incisors darker than shade C2.
Who cannot join
- Participants that had undergone tooth-whitening procedures
- Participants that had labial anterior restorations, were pregnant or lactating.
- Participants with severe internal tooth discoloration (such as tetracycline stains, fluorosis, pulpless teeth).
- Participants with bruxism habits or any gross pathology in the mouth
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry - Universidade Estadual de Ponta Grossa
Ponta Grossa, Paraná, 84030-900
About this study
Official title: Color Change and Sensitivity Level for In-office Bleaching With and Without a LED/Laser Device
There is a controversy in the dentistry literature about how the use of associated light to activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the bleaching effectiveness. The studies that demonstrated an increased level of bleaching using light activation employed lower hydrogen peroxide gels while the ones reporting no statistical difference employed higher hydrogen peroxide gels.
The hypothesis of this study is that the effectiveness of light activation tooth bleaching in dependent on the hydrogen peroxide concentration employed.
Read the detailed description
The aim of this study is to compare the color change and tooth sensitivity of in-office bleaching using different hydrogen peroxide concentrations and with or without light activation. Sixty patients will be enrolled in this trial and divide equally into 4 groups according to the combination of the main factors hydrogen peroxide concentration (35% or 20%) or LED/laser activation (yes or no). Three 15-min applications will be performed in each clinical appointment. A LED/laser device will be used in the respective groups for three 1-min application with an interval of 2 min. The same procedure will be repeated one week later. The color change will be assessed after hte 1st and 2nd session, after 1 week and 6 months of the end of the treatment using a value-oriented shade Vita Classical and a spectrophotometer Easy Shade. The tooth sensitivity will be reported by patients using a 0 to 10 visual analog scale. The Student t test (α = .05) will be used to compare the tooth color changes and the intensity of tooth sensitivity between groups at baseline and immediately after the first and second bleaching appointments. The Fisher exact test and Student t test (α = .05), respectively, will be used to analyze the percentage of patients with tooth sensitivity and its intensity.
- Conditions
- Tooth Discoloration
- Being tested
- in-office bleaching with/without light
- Keywords
- tooth bleaching, bleaching agent, hydrogen peroxide
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-office bleaching with/without lightProcedure or surgery
Also called Tooth bleaching, Hydrogen peroxide, In-office bleaching, Light activation
Two clinical sessions of tooth bleaching will be performed in each patient with a 1-week interval between them. In each session, three 15-min applications of the gel will be done using one of the two concentrations under investigation. In half of the sample of each concentration, the gel will be activated with a LED/laser device for a total of 3 min, as specified by the DMC manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| 35% hydrogen peroxide control | Active comparator | The tooth bleaching will be performed using a high hydrogen peroxide concentration (35%) without light-activation with LED/light device Receives: Procedure: in-office bleaching with/without light |
| 20% hydrogen peroxide | Active comparator | The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) without light activation with a LED/laser device Receives: Procedure: in-office bleaching with/without light |
| 35% hydrogen peroxide + light | Experimental | The tooth bleaching will be performed with a high hydrogen peroxide concentration (35%) associated with LED/laser light activation Receives: Procedure: in-office bleaching with/without light |
| 20% hydrogen peroxide + light | Experimental | The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) associated with LED/laser light activation Receives: Procedure: in-office bleaching with/without light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in color
The change in color will be measured using Vita Shade Classical scale at baseline and after the end of the bleaching protocol.
A spectrophootometer Easy Shade will also be used and the coordinates of the CIELab system will be recorded.
Measured: at the 2-week recall
Secondary outcomes (1)
Prevalence and intensity of tooth sensitivity
The visual analog scale will be used for patients to record their tooth sensitivity in a 0 to 10 scale.
Measured: 24-hours after the bleaching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ponta Grossa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Reis, Universidade Estadual de Ponta Grossa
- Investigators
- Alessandra Reis, DDS, MS, Principal investigator, Universidade Estadual de Ponta Grossa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231243
- Sponsor's protocol ID
- ARAL001
- Status last verified
- Dec 2011
- First submitted
- 28 Oct 2010
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Change and Sensitivity Level for In-office Bleaching With and Without a LED/Laser Device
- ClinicalTrials.gov ID
- NCT01231243
- Acronym / sponsor ID
- ARAL001
- Conditions
- Tooth Discoloration
- Keywords
- tooth bleaching, bleaching agent, hydrogen peroxide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Estadual de Ponta GrossaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Nov 2010 (estimated)
- 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.
There is a controversy in the dentistry literature about how the use of associated light to activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the bleaching effectiveness. The studies that demonstrated an increased level of bleaching using light activation employed lower hydrogen peroxide gels while the ones reporting no statistical difference employed higher hydrogen peroxide gels.
The hypothesis of this study is that the effectiveness of light activation tooth bleaching in dependent on the hydrogen peroxide concentration employed.
Detailed description
The aim of this study is to compare the color change and tooth sensitivity of in-office bleaching using different hydrogen peroxide concentrations and with or without light activation. Sixty patients will be enrolled in this trial and divide equally into 4 groups according to the combination of the main factors hydrogen peroxide concentration (35% or 20%) or LED/laser activation (yes or no). Three 15-min applications will be performed in each clinical appointment. A LED/laser device will be used in the respective groups for three 1-min application with an interval of 2 min. The same procedure will be repeated one week later. The color change will be assessed after hte 1st and 2nd session, after 1 week and 6 months of the end of the treatment using a value-oriented shade Vita Classical and a spectrophotometer Easy Shade. The tooth sensitivity will be reported by patients using a 0 to 10 visual analog scale. The Student t test (α = .05) will be used to compare the tooth color changes and the intensity of tooth sensitivity between groups at baseline and immediately after the first and second bleaching appointments. The Fisher exact test and Student t test (α = .05), respectively, will be used to analyze the percentage of patients with tooth sensitivity and its intensity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 35% hydrogen peroxide control | Active comparator | Procedure: in-office bleaching with/without lightThe tooth bleaching will be performed using a high hydrogen peroxide concentration (35%) without light-activation with LED/light device |
| 20% hydrogen peroxide | Active comparator | Procedure: in-office bleaching with/without lightThe tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) without light activation with a LED/laser device |
| 35% hydrogen peroxide + light | Experimental | Procedure: in-office bleaching with/without lightThe tooth bleaching will be performed with a high hydrogen peroxide concentration (35%) associated with LED/laser light activation |
| 20% hydrogen peroxide + light | Experimental | Procedure: in-office bleaching with/without lightThe tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) associated with LED/laser light activation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants should be at least 18 years old;
- Participants should have good general and oral health
- Participants should have six caries-free maxillary anterior teeth without restorations on the labial surfaces
- Participants should be willing to sign a consent form
- Participants should have central incisors darker than shade C2.
Key exclusion criteria (4 listed)
- Participants that had undergone tooth-whitening procedures
- Participants that had labial anterior restorations, were pregnant or lactating.
- Participants with severe internal tooth discoloration (such as tetracycline stains, fluorosis, pulpless teeth).
- Participants with bruxism habits or any gross pathology in the mouth
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 |
|---|---|---|
| in-office bleaching with/without lightAlso: Tooth bleaching, Hydrogen peroxide, In-office bleaching, Light activationTwo clinical sessions of tooth bleaching will be performed in each patient with a 1-week interval between them. In each session, three 15-min applications of the gel will be done using one of the two concentrations under investigation. In half of the sample of each concentration, the gel will be activated with a LED/laser device for a total of 3 min, as specified by the DMC manufacturer. | Procedure or surgery | 20% hydrogen peroxide, 20% hydrogen peroxide + light, 35% hydrogen peroxide + light, 35% hydrogen peroxide control |
Primary outcome
Change in color
Time frame: at the 2-week recall
The change in color will be measured using Vita Shade Classical scale at baseline and after the end of the bleaching protocol. A spectrophootometer Easy Shade will also be used and the coordinates of the CIELab system will be recorded.
1 secondary outcome
Prevalence and intensity of tooth sensitivity
Time frame: 24-hours after the bleaching
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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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.
Alessandra Reis, DDS, MS principal investigator
Universidade Estadual de Ponta Grossa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing in-office bleaching with/without light in people with Tooth Discoloration, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
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: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in color (time frame: at the 2-week recall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2011.