Tooth BleachingNCT03207204
In-office Bleaching Using a Violet Light
A study testing 35% Hydrogen peroxide bleaching, 30% Carbamide peroxide bleaching and Violet LED bleaching 1 in people with Tooth Bleaching and Dentin Sensitivity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching, Dentin Sensitivity
- What is being tested?
- 35% Hydrogen peroxide bleaching, 30% Carbamide peroxide bleaching and Violet LED bleaching 1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jul 2017to 2 Jul 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of all the teeth, without restorations or caries on anterior teeth.
- Patients presenting the canine tooth color A3 (according to Vita classical scale) or darker.
Who cannot join
- Patients presenting systemic pathologies
- Patients presenting periodontal diseases
- Smokers or patients with systematic use of alcohol
- Patients presenting teeth with color alterations by tetracycline, fluorosis, endodontic treatments.
- Patients with historic of self-referenced sensitivity
- Pregnant or Breastfeeding period patients
- Presence of restorations on anterior teeth
- Patients presenting bruxism or systematic use of analgesics or anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Clinical Evaluation of In-office Dental Bleaching Using a Violet Light (405-410 nm)
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life. After being informed of the objectives of the study, 200 participants will be selected and randomly divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1 session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2 sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); G6 - Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week); G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week); G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). The color evaluation will be performed at predetermined times (before and immediately after treatment, 14 days after completion of bleaching and 3, 6 and 12 months after completion of bleaching), and quantitatively evaluated by colorimetric tests (objective and subjective) and spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction (descriptive evaluation), will be subjected to statistical analysis to determine the homogeneity and normality of the sample and for comparison between treatment groups, considering a 5% significance level.
Read the detailed description
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life.
This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo (Protocol# 1.981.756). The experimental design is in according to CONSORT. The present research will be a blind, parallel and randomized study with similar allocation between the treatment groups. It will be included 200 participants, selected among the patients of the Special Laboratory of lasers in dentistry (LELO-FOUSP). After being being informed of the objectives of the study the participants will be randomly divided into a treatment group (n = 25):
G1 - In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week).
G2 - In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week).
G3 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week).
G4 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week).
G5 - In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week).
G6 - In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week).
G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week).
G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).
The primary outcome of this study is the color alteration, which will be evaluated quantitatively by colorimetric (subjective) and spectrophotometric (objective) tests. Additionally, will be evaluated dental sensitivity during and after treatment (predetermined times), patient satisfaction regarding the treatment, and impact on patient quality of life (questionnaire OHIP-14).
The color measurement will be blind, in predetermined times (before the treatment, immediately after the treatment, 14 days after, 3 months after, 6 months after and 12 months after). It will be performed by two methods: subjectively, with a color scale; and objectively, with a clinical spectrophotometer.
The evaluation of dental sensitivity will be measured with a Visual analogue scale (VAS). It will be performed immediately after the treatment and 48 hours after the treatment.
The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment, and will be applied 14 days after the end of treatment, 3 months after, 6 months after and 12 months after.
The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire, which will be applied after the end of the treatment.
- Conditions
- Tooth Bleaching, Dentin Sensitivity
- Being tested
- 35% Hydrogen peroxide bleaching, 30% Carbamide peroxide bleaching, Violet LED bleaching 1, Violet LED bleaching 2, Photochemical protocol 1
- Keywords
- Dental bleaching, Color, Sensitivity, violet LED, Quality of life
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35% Hydrogen peroxide bleachingProcedure or surgery
Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
30% Carbamide peroxide bleachingProcedure or surgery
Protocol: Application of 35% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
Violet LED bleaching 1Procedure or surgery
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Violet LED bleaching 2Procedure or surgery
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 2 times a week.
Photochemical protocol 1Procedure or surgery
Protocol: Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Photochemical protocol 2Procedure or surgery
Protocol: Application of 30% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Hybrid technique 1Procedure or surgery
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 35% Hydrogen peroxide to act concomitantly with the light.
Hybrid technique 2Procedure or surgery
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 30% Carbamide peroxide to act concomitantly with the light.
| Study group | Role | What they receive |
|---|---|---|
| G1 - 35% Hydrogen peroxide bleaching | Active comparator | In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week); Receives: Procedure: 35% Hydrogen peroxide bleaching |
| G2 - 30% Carbamide peroxide bleaching | Active comparator | In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week); Receives: Procedure: 30% Carbamide peroxide bleaching |
| G3 - Violet LED bleaching 1 | Experimental | In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week); Receives: Procedure: Violet LED bleaching 1 |
| G4 - Violet LED bleaching 2 | Experimental | In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week); Receives: Procedure: Violet LED bleaching 2 |
| G5 - Photochemical protocol 1 | Experimental | In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); Receives: Procedure: Photochemical protocol 1 |
| G6 - Photochemical protocol 2 | Experimental | In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week) Receives: Procedure: Photochemical protocol 2 |
| G7 - Hybrid technique 1 | Experimental | hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week) Receives: Procedure: Hybrid technique 1 |
| G8 - Hybrid technique 2 | Experimental | Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). Receives: Procedure: Hybrid technique 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color alteration
The color measurement will be blind, in predetermined time (12 months after the treatment). It will be performed with a clinical spectrophotometer.
Measured: 12 months after the treatment
Secondary outcomes (5)
Dental sensitivity
The evaluation of dental sensitivity will be measured with a Visual analogue scale (VAS). It will be performed immediately after the treatment and 48 hours after the treatment.
Measured: Immediately after the treatment and 48 hours after the treatment
Patient satisfaction regarding the treatment
The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment, and will be applied 14 days after the end of treatment, 3 months after, 6 months after and 12 months after.
Measured: 14 days after the end of treatment, 3 months after, 6 months after and 12 months after
Quality of life of the patients
The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire, which will be applied after the end of the treatment.
Measured: Immediately after the end of bleaching
Color change throughout 12 months with a visual color scale
The evaluation will be performed with a visual color scale
Measured: Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching
Color change throughout 6 months with a clinical spectrophotometer
The evaluation will be performed with a clinical spectrophotometer
Measured: Before, immediately after, 14 days, 3 months and 6 months after bleaching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start2 Jul 2017
- Primary completion2 Dec 2017
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth BleachingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Moreira de Freitas, University of Sao Paulo
- Investigators
- Patricia Freitas, PhD, Study chair, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207204
- Sponsor's protocol ID
- 010
- Status last verified
- Nov 2020
- First submitted
- 22 Jun 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
PubMed 20166405Boushell LW, Ritter AV, Garland GE, Tiwana KK, Smith LR, Broome A, Leonard RH. Nightguard vital bleaching: side effects and patient satisfaction 10 to 17 years post-treatment. J Esthet Restor Dent. 2012 Jun;24(3):211-9. doi: 10.1111/j.1708-8240.2011.00479.x. Epub 2011 Oct 11.
PubMed 22691084
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Evaluation of In-office Dental Bleaching Using a Violet Light (405-410 nm)
- ClinicalTrials.gov ID
- NCT03207204
- Acronym / sponsor ID
- 010
- Conditions
- Tooth Bleaching, Dentin Sensitivity
- Keywords
- Dental bleaching, Color, Sensitivity, violet LED, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- 2 Dec 2017 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 2 Jul 2017 (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 objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life. After being informed of the objectives of the study, 200 participants will be selected and randomly divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1 session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2 sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); G6 - Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week); G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week); G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). The color evaluation will be performed at predetermined times (before and immediately after treatment, 14 days after completion of bleaching and 3, 6 and 12 months after completion of bleaching), and quantitatively evaluated by colorimetric tests (objective and subjective) and spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction (descriptive evaluation), will be subjected to statistical analysis to determine the homogeneity and normality of the sample and for comparison between treatment groups, considering a 5% significance level.
Detailed description
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life.
This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo (Protocol# 1.981.756). The experimental design is in according to CONSORT. The present research will be a blind, parallel and randomized study with similar allocation between the treatment groups. It will be included 200 participants, selected among the patients of the Special Laboratory of lasers in dentistry (LELO-FOUSP). After being being informed of the objectives of the study the participants will be randomly divided into a treatment group (n = 25):
G1 - In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week).
G2 - In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week).
G3 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week).
G4 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week).
G5 - In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week).
G6 - In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week).
G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week).
G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).
The primary outcome of this study is the color alteration, which will be evaluated quantitatively by colorimetric (subjective) and spectrophotometric (objective) tests. Additionally, will be evaluated dental sensitivity during and after treatment (predetermined times), patient satisfaction regarding the treatment, and impact on patient quality of life (questionnaire OHIP-14).
The color measurement will be blind, in predetermined times (before the treatment, immediately after the treatment, 14 days after, 3 months after, 6 months after and 12 months after). It will be performed by two methods: subjectively, with a color scale; and objectively, with a clinical spectrophotometer.
The evaluation of dental sensitivity will be measured with a Visual analogue scale (VAS). It will be performed immediately after the treatment and 48 hours after the treatment.
The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment, and will be applied 14 days after the end of treatment, 3 months after, 6 months after and 12 months after.
The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire, which will be applied after the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| G1 - 35% Hydrogen peroxide bleaching | Active comparator | Procedure: 35% Hydrogen peroxide bleachingIn-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week); |
| G2 - 30% Carbamide peroxide bleaching | Active comparator | Procedure: 30% Carbamide peroxide bleachingIn-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week); |
| G3 - Violet LED bleaching 1 | Experimental | Procedure: Violet LED bleaching 1In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week); |
| G4 - Violet LED bleaching 2 | Experimental | Procedure: Violet LED bleaching 2In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week); |
| G5 - Photochemical protocol 1 | Experimental | Procedure: Photochemical protocol 1In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); |
| G6 - Photochemical protocol 2 | Experimental | Procedure: Photochemical protocol 2In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week) |
| G7 - Hybrid technique 1 | Experimental | Procedure: Hybrid technique 1hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week) |
| G8 - Hybrid technique 2 | Experimental | Procedure: Hybrid technique 2Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Presence of all the teeth, without restorations or caries on anterior teeth.
- Patients presenting the canine tooth color A3 (according to Vita classical scale) or darker.
Key exclusion criteria (8 listed)
- Patients presenting systemic pathologies
- Patients presenting periodontal diseases
- Smokers or patients with systematic use of alcohol
- Patients presenting teeth with color alterations by tetracycline, fluorosis, endodontic treatments.
- Patients with historic of self-referenced sensitivity
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 |
|---|---|---|
| 35% Hydrogen peroxide bleachingApplication of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions. | Procedure or surgery | G1 - 35% Hydrogen peroxide bleaching |
| 30% Carbamide peroxide bleachingProtocol: Application of 35% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions. | Procedure or surgery | G2 - 30% Carbamide peroxide bleaching |
| Violet LED bleaching 1Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week. | Procedure or surgery | G3 - Violet LED bleaching 1 |
| Violet LED bleaching 2Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 2 times a week. | Procedure or surgery | G4 - Violet LED bleaching 2 |
| Photochemical protocol 1Protocol: Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week. | Procedure or surgery | G5 - Photochemical protocol 1 |
| Photochemical protocol 2Protocol: Application of 30% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week. | Procedure or surgery | G6 - Photochemical protocol 2 |
| Hybrid technique 1Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 35% Hydrogen peroxide to act concomitantly with the light. | Procedure or surgery | G7 - Hybrid technique 1 |
| Hybrid technique 2Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 30% Carbamide peroxide to act concomitantly with the light. | Procedure or surgery | G8 - Hybrid technique 2 |
Primary outcome
Color alteration
Time frame: 12 months after the treatment
The color measurement will be blind, in predetermined time (12 months after the treatment). It will be performed with a clinical spectrophotometer.
5 secondary outcomes
Dental sensitivity
Time frame: Immediately after the treatment and 48 hours after the treatment
Patient satisfaction regarding the treatment
Time frame: 14 days after the end of treatment, 3 months after, 6 months after and 12 months after
Quality of life of the patients
Time frame: Immediately after the end of bleaching
Color change throughout 12 months with a visual color scale
Time frame: Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching
Color change throughout 6 months with a clinical spectrophotometer
Time frame: Before, immediately after, 14 days, 3 months and 6 months after 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 4 Nov 2020.
- Background: PubMed 20166405Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
- Background: PubMed 22691084Boushell LW, Ritter AV, Garland GE, Tiwana KK, Smith LR, Broome A, Leonard RH. Nightguard vital bleaching: side effects and patient satisfaction 10 to 17 years post-treatment. J Esthet Restor Dent. 2012 Jun;24(3):211-9. doi: 10.1111/j.1708-8240.2011.00479.x. Epub 2011 Oct 11.
- 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.
Patricia Freitas, PhD study chair
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 35% Hydrogen peroxide bleaching, 30% Carbamide peroxide bleaching and Violet LED bleaching 1 in people with Tooth Bleaching and Dentin Sensitivity, run by University of Sao Paulo 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 2 inclusion and 8 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 4 Nov 2020. 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.
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?
Color alteration (time frame: 12 months after the treatment). 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 NCT03207204, which also lists 2 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 4 Nov 2020.