Tooth BleachingPhase 1NCT04013659
Effect of Gel Renewal During In-office Dental Bleaching
A Phase 1 study testing Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation in people with Tooth Bleaching, run by Universidade Ibirapuera at 1 site in Brazil.
Trial summary
Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and… 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
- What is being tested?
- Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to 1 Apr 2020
- Phase
- Phase 1
- 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
- Good oral hygiene conditions
- Good general health conditions and without systemic disease
- Presence of all teeth, without caries, periodontal disease, restorations, endodontic treatment, crowns
- Patients with dental color A3 or darker, according to the VITA * Classical Color Scale.
Who cannot join
- Pregnant and lactating female patients
- Presence of caries, periodontal disease or any other infectious source in the oral cavity
- Systematic use of tobacco and alcoholic beverages
- Chronic use of corticosteroids, as well as who makes use of analgesics or anti-inflammatories before or during 48 hours after dental bleaching
- Patients with dentin hypersensitivity
- Patients with tooth color alteration by tetracycline, fluorosis, endodontic treatment.
- Volunteers who use removable prostheses
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Ibirapuera
São Paulo, São Paulo, 04661-100
Karen M Ramalho, PhD, +55 11 989385397, karenramalho@hotmail.com
About this study
Official title: Effect of Gel Renewal During In-office Dental Bleaching Using Violet LED Light as Photo-accelerator. A Randomized Blind Clinical Trial
Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and postoperative sensitivity in a randomized, blinded, split-mouth study. Thirty-three volunteers will be selected to participate in the study (n = 33), and the study groups will be: G1 (Permanence of the Whitening Gel on the tooth enamel for 15 minutes) and G2 (3 Whitening Gel renewal every 5 minutes - Total of 15 minutes). In both G1 and G2, teeth will be illuminated with the Violet LED (405-410nm). In the same patient the two treatments (G1 and G2) will be performed, with a split-mouth protocol. The primary outcome will be immediate and mediated color change, quantitatively assessed by colorimetric (color scale) and spectrophotometry tests. Dental sensitivity will also be evaluated during and after tooth whitening using the VAS pain scale. There will be 3 whitening sessions with a 7-day interval between them. The alteration of color and presence of sensitivity will also be evaluated at the times of 14 days and 2 months after the whitening ends. A gel containing 35% hydrogen peroxide will be used. The final color evaluator and responsible for interviewing the patient about the sensitivity will be blind as to which treatment was applied on each side of the patient's arcade.
- Conditions
- Tooth Bleaching
- Being tested
- Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Bleaching with 35% hydrogen peroxide gel + Violet LED IrradiationOther
After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED
| Study group | Role | What they receive |
|---|---|---|
| G1 - Permanence of the Whitening Gel | Experimental | Permanence of the Whitening Gel (Biological Product: 35% Hydrogen Peroxide) on the tooth enamel during the 15 minutes of dental-bleaching Receives: Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation |
| G2 - Renewal of the Whitening Gel | Experimental | 3 Whitening Gel (Biological Product: 35% Hydrogen Peroxide) renewal every 5 minutes during the 15 minutes of dental-bleaching Receives: Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teeth Color 1
assessed quantitatively by colorimetric color scale
Measured: Immediately after treatment
Teeth Color 2
assessed quantitatively by spectrophotometry
Measured: Immediately after treatment
Teeth Color 1
assessed quantitatively by colorimetric color scale
Measured: 14 days after treatment
Teeth Color 2
assessed quantitatively by spectrophotometry
Measured: 14 days after treatment
Teeth Color 1
assessed quantitatively by colorimetric color scale
Measured: 2 months after treatment
Teeth Color 2
assessed quantitatively by spectrophotometry
Measured: 2 months after treatment
Secondary outcomes (3)
Dental sensitivity
Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)
Measured: Immediately after treatment
Dental sensitivity
Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)
Measured: 14 days after treatment
Dental sensitivity
Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)
Measured: 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Mar 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split-mouth model design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Ibirapuera
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Karen Müller Ramalho, Universidade Ibirapuera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013659
- Sponsor's protocol ID
- 90670218.3.0000.5597
- Status last verified
- Jul 2019
- First submitted
- 9 Jun 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gel Renewal During In-office Dental Bleaching Using Violet LED Light as Photo-accelerator. A Randomized Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04013659
- Acronym / sponsor ID
- 90670218.3.0000.5597
- Conditions
- Tooth Bleaching
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universidade IbirapueraUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 10 Jul 2019 (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.
Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and postoperative sensitivity in a randomized, blinded, split-mouth study. Thirty-three volunteers will be selected to participate in the study (n = 33), and the study groups will be: G1 (Permanence of the Whitening Gel on the tooth enamel for 15 minutes) and G2 (3 Whitening Gel renewal every 5 minutes - Total of 15 minutes). In both G1 and G2, teeth will be illuminated with the Violet LED (405-410nm). In the same patient the two treatments (G1 and G2) will be performed, with a split-mouth protocol. The primary outcome will be immediate and mediated color change, quantitatively assessed by colorimetric (color scale) and spectrophotometry tests. Dental sensitivity will also be evaluated during and after tooth whitening using the VAS pain scale. There will be 3 whitening sessions with a 7-day interval between them. The alteration of color and presence of sensitivity will also be evaluated at the times of 14 days and 2 months after the whitening ends. A gel containing 35% hydrogen peroxide will be used. The final color evaluator and responsible for interviewing the patient about the sensitivity will be blind as to which treatment was applied on each side of the patient's arcade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth model design
| Arm | Type | Receives |
|---|---|---|
| G1 - Permanence of the Whitening Gel | Experimental | Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED IrradiationPermanence of the Whitening Gel (Biological Product: 35% Hydrogen Peroxide) on the tooth enamel during the 15 minutes of dental-bleaching |
| G2 - Renewal of the Whitening Gel | Experimental | Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation3 Whitening Gel (Biological Product: 35% Hydrogen Peroxide) renewal every 5 minutes during the 15 minutes of dental-bleaching |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good oral hygiene conditions
- Good general health conditions and without systemic disease
- Presence of all teeth, without caries, periodontal disease, restorations, endodontic treatment, crowns
- Patients with dental color A3 or darker, according to the VITA * Classical Color Scale.
Key exclusion criteria (7 listed)
- Pregnant and lactating female patients
- Presence of caries, periodontal disease or any other infectious source in the oral cavity
- Systematic use of tobacco and alcoholic beverages
- Chronic use of corticosteroids, as well as who makes use of analgesics or anti-inflammatories before or during 48 hours after dental bleaching
- Patients with dentin hypersensitivity
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 |
|---|---|---|
| Dental Bleaching with 35% hydrogen peroxide gel + Violet LED IrradiationAfter gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED | Other | G1 - Permanence of the Whitening Gel, G2 - Renewal of the Whitening Gel |
Primary outcome
Teeth Color 1
Time frame: Immediately after treatment
assessed quantitatively by colorimetric color scale
Teeth Color 2
Time frame: Immediately after treatment
assessed quantitatively by spectrophotometry
Teeth Color 1
Time frame: 14 days after treatment
assessed quantitatively by colorimetric color scale
Teeth Color 2
Time frame: 14 days after treatment
assessed quantitatively by spectrophotometry
Teeth Color 1
Time frame: 2 months after treatment
assessed quantitatively by colorimetric color scale
Teeth Color 2
Time frame: 2 months after treatment
assessed quantitatively by spectrophotometry
3 secondary outcomes
Dental sensitivity
Time frame: Immediately after treatment
Dental sensitivity
Time frame: 14 days after treatment
Dental sensitivity
Time frame: 2 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation in people with Tooth Bleaching, run by Universidade Ibirapuera 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 4 inclusion and 7 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 10 Jul 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Karen M Ramalho, PhD (11989385397 ext. +5511, karenramalho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teeth Color 1 (time frame: Immediately after treatment). The study lists 6 primary outcomes in all. 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 10 Jul 2019.