ColorNCT06165458
Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs
A study testing 6% hydrogen peroxide gel + violet LED, 6% hydrogen peroxide gel + blue LED and 35% hydrogen peroxide gel + violet LED in people with Color and Bleaching Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This is a randomized, controlled, double-blind and repeated-measures clinical trial evaluated the photoactivation of hydrogen peroxide gels in different concentrations with blue or violet LED in terms of whitening efficacy and tooth sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Color, Bleaching Sensitivity
- What is being tested?
- 6% hydrogen peroxide gel + violet LED, 6% hydrogen peroxide gel + blue LED and 35% hydrogen peroxide gel + violet LED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jan 2021to 15 Feb 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at age 18 or older, with good general and oral health;
- possessing all six natural and healthy upper anterior teeth with a color shade of A2 or darker, determined by comparison with the Vita Classic scale;
Who cannot join
- pregnant and breastfeeding women;
- individuals with internal tooth discoloration (tetracycline stains, fluorosis or hypoplasias);
- smokers, or those with veneers or restorations on the teeth in questions were excluded;
- gingival recession;
- dentin exposure;
- periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs
This is a randomized, controlled, double-blind and repeated-measures clinical trial evaluated the photoactivation of hydrogen peroxide gels in different concentrations with blue or violet LED in terms of whitening efficacy and tooth sensitivity.
- Conditions
- Color, Bleaching Sensitivity
- Being tested
- 6% hydrogen peroxide gel + violet LED, 6% hydrogen peroxide gel + blue LED, 35% hydrogen peroxide gel + violet LED, 35% hydrogen peroxide gel + blue LED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% hydrogen peroxide gel + violet LEDOther
Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by violet LED
6% hydrogen peroxide gel + blue LEDOther
Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by blue LED
35% hydrogen peroxide gel + violet LEDOther
Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by violet LED
35% hydrogen peroxide gel + blue LEDOther
Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by blue LED
| Study group | Role | What they receive |
|---|---|---|
| HP6V | Experimental | 6% hydrogen peroxide gel + violet LED Receives: Other: 6% hydrogen peroxide gel + violet LED |
| HP6B | Experimental | 6% hydrogen peroxide gel + blue LED Receives: Other: 6% hydrogen peroxide gel + blue LED |
| HP35V | Experimental | 35% hydrogen peroxide gel + violet LED Receives: Other: 35% hydrogen peroxide gel + violet LED |
| HP35B | Experimental | 35% hydrogen peroxide gel + blue LED Receives: Other: 35% hydrogen peroxide gel + blue LED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color
A operator measured the color of the six upper anterior teeth using a digital spectrophotometer (VITA Easyshade V, Wilcos, Petrópolis, RJ, Brazil).
Measured: Color assessment was carried out before bleaching, 1 week after bleaching and 3 months after bleaching
Bleaching Sensitivity
The degree of tooth sensitivity of patients was recorded using a visual analogue scale (VAS) from 0 to 10, where 0 represents no tooth sensitivity and 10 represents the greatest tooth sensitivity ever felt by the patient.
Measured: Assessments were carried out three times: before bleaching, immediately after bleaching, and 24 hours after bleaching.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start12 Jan 2021
- Primary completion3 Nov 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165458
- Sponsor's protocol ID
- UFPara017
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oliveira MGVV, Dutra DJB, Costa JLSG, Besegato JF, Barros APO, Oliveira RR, Araujo PV, Alvim HH. Clinical comparison of whitening efficacy and tooth sensitivity of different concentrations of hydrogen peroxide photoactivated with violet or blue LEDs. Lasers Med Sci. 2024 Jul 26;39(1):195. doi: 10.1007/s10103-024-04144-6.
PubMed 39060473
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs
- ClinicalTrials.gov ID
- NCT06165458
- Acronym / sponsor ID
- UFPara017
- Conditions
- Color, Bleaching Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 11 Dec 2023 (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.
This is a randomized, controlled, double-blind and repeated-measures clinical trial evaluated the photoactivation of hydrogen peroxide gels in different concentrations with blue or violet LED in terms of whitening efficacy and tooth sensitivity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HP6V | Experimental | Other: 6% hydrogen peroxide gel + violet LED6% hydrogen peroxide gel + violet LED |
| HP6B | Experimental | Other: 6% hydrogen peroxide gel + blue LED6% hydrogen peroxide gel + blue LED |
| HP35V | Experimental | Other: 35% hydrogen peroxide gel + violet LED35% hydrogen peroxide gel + violet LED |
| HP35B | Experimental | Other: 35% hydrogen peroxide gel + blue LED35% hydrogen peroxide gel + blue LED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at age 18 or older, with good general and oral health;
- possessing all six natural and healthy upper anterior teeth with a color shade of A2 or darker, determined by comparison with the Vita Classic scale;
Key exclusion criteria (6 listed)
- pregnant and breastfeeding women;
- individuals with internal tooth discoloration (tetracycline stains, fluorosis or hypoplasias);
- smokers, or those with veneers or restorations on the teeth in questions were excluded;
- gingival recession;
- dentin exposure;
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 |
|---|---|---|
| 6% hydrogen peroxide gel + violet LEDTooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by violet LED | Other | HP6V |
| 6% hydrogen peroxide gel + blue LEDTooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by blue LED | Other | HP6B |
| 35% hydrogen peroxide gel + violet LEDTooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by violet LED | Other | HP35V |
| 35% hydrogen peroxide gel + blue LEDTooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by blue LED | Other | HP35B |
Primary outcome
Color
Time frame: Color assessment was carried out before bleaching, 1 week after bleaching and 3 months after bleaching
A operator measured the color of the six upper anterior teeth using a digital spectrophotometer (VITA Easyshade V, Wilcos, Petrópolis, RJ, Brazil).
Bleaching Sensitivity
Time frame: Assessments were carried out three times: before bleaching, immediately after bleaching, and 24 hours after bleaching.
The degree of tooth sensitivity of patients was recorded using a visual analogue scale (VAS) from 0 to 10, where 0 represents no tooth sensitivity and 10 represents the greatest tooth sensitivity ever felt by the patient.
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 15 Dec 2023.
- Derived from this study: PubMed 39060473Oliveira MGVV, Dutra DJB, Costa JLSG, Besegato JF, Barros APO, Oliveira RR, Araujo PV, Alvim HH. Clinical comparison of whitening efficacy and tooth sensitivity of different concentrations of hydrogen peroxide photoactivated with violet or blue LEDs. Lasers Med Sci. 2024 Jul 26;39(1):195. doi: 10.1007/s10103-024-04144-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6% hydrogen peroxide gel + violet LED, 6% hydrogen peroxide gel + blue LED and 35% hydrogen peroxide gel + violet LED in people with Color and Bleaching Sensitivity, run by Universidade Federal do Para 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 6 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 15 Dec 2023. 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 (time frame: Color assessment was carried out before bleaching, 1 week after bleaching and 3 months after bleaching). The study lists 2 primary outcomes in all. 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 NCT06165458, which also lists 1 linked publication.
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 15 Dec 2023.