Sensitivity, ToothPhase 1/2NCT05789004
Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition
A Phase 1/2 study testing Tooth Bleaching with Whiteness HP Automixx 35% and Tooth Bleaching with Whiteness HP Automixx 6% in people with Sensitivity, Tooth, run by University of Nove de Julho.
Trial summary
The aesthetics of dental elements generates great psychological and social impacts, both in the deciduous and permanent dentition. One of the techniques widely used to visually improve the appearance of teeth is bleaching. Bleaching can be performed both at home and in a dental office. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Tooth
- What is being tested?
- Tooth Bleaching with Whiteness HP Automixx 35% and Tooth Bleaching with Whiteness HP Automixx 6%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 20 Mar 2026
- Phase
- Phase 1/2
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range from 03 to 06 years old;
- Vital or non-vital teeth (already endodontically treated) with severe to moderate discoloration;
- No active carious lesions;
- No lesions in the oral cavity;
- No report of previous tooth sensitivity.
Who cannot join
- Patients who during anamnesis report allergies to dyes or latex, who withdraw from participating in the study, as well as those who do not attend the callbacks, will be excluded.
About this study
Official title: Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition: Study Protocol for a Randomized Controlled Clinical Trial
The aesthetics of dental elements generates great psychological and social impacts, both in the deciduous and permanent dentition. One of the techniques widely used to visually improve the appearance of teeth is bleaching. Bleaching can be performed both at home and in a dental office. In office whitening, the technique used consists of applying the whitening gel to the dental surfaces in concentrations ranging from 25% to 50% of hydrogen peroxide. However, recent studies show that low and medium concentration bleaching agents based on hydrogen peroxide have been effective and present a lower risk of sensitivity to the patient. In view of the above, this study aims to carry out a controlled and randomized clinical trial to compare the effectiveness of dental bleaching in deciduous teeth with hydrogen peroxide at concentrations of 35% and 6%. For this, 38 patients aged 03 to 06 years will be selected, allocated in 2 groups (G1 - Hydrogen Peroxide 35%, n=19 and G2- Hydrogen Peroxide 6%, n=19). Bleaching will be carried out in up to three sessions, with an interval of 7 days between them and the evaluation of color and tooth sensitivity will be carried out 48 hours after each bleaching session. The color assessment will be measured using a digital spectrometer and tooth sensitivity using the Pain Level Scale (Wong-Baker Faces®). Descriptive statistical analysis will be carried out, containing the mean and standard deviation in the calculation and normality and homogeneity tests will be carried out, for subsequent adequate statistical analysis. As a result, it is expected that there is no significant difference between the groups in terms of color variation and that the low-concentration bleaching group has the lowest sensitivity index.
- Conditions
- Sensitivity, Tooth
- Being tested
- Tooth Bleaching with Whiteness HP Automixx 35%, Tooth Bleaching with Whiteness HP Automixx 6%
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth Bleaching with Whiteness HP Automixx 35%Procedure or surgery
- Clinical examination and taking the initial shade of the tooth with Vita Easyshade®;
- Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®);
- Prophylaxis with a Robson brush and prophylactic paste;
- Application of lip balm on the patient's lips;
- Placement of the labial retractor;
- Application of the gingival barrier;
- Application of Whiteness HP Automixx 35% whitening gel;
- In the session, a single application of the gel will be carried out and where it will remain on the surface of the tooth for 15 min;
- The gel must be removed from the teeth with a sucker and the teeth cleaned with gauze;
- Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®);
- The second bleaching session will be carried out 7 days after the first one and, if necessary, a third session can be carried out 7 days after the second one.
Tooth Bleaching with Whiteness HP Automixx 6%Procedure or surgery
- Clinical examination and taking the initial shade of the tooth with Vita Easyshade®;
- Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®);
- Prophylaxis with a Robson brush and prophylactic paste;
- Application of lip balm on the patient's lips;
- Placement of the labial retractor;
- Application of the gingival barrier;
- Application of Whiteness HP Automixx 6% whitening gel;
- In the session, a single application of the gel will be carried out and where it will remain on the surface of the tooth for 15 min;
- The gel must be removed from the teeth with a sucker and the teeth cleaned with gauze;
- Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®);
- The second bleaching session will be carried out 7 days after the first one and, if necessary, a third session can be carried out 7 days after the second one.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen Peroxide 35% | Experimental | In the participants of this group, the tooth whitening process will be performed with 35% hydrogen peroxide. Receives: Procedure: Tooth Bleaching with Whiteness HP Automixx 35% |
| Hydrogen Peroxide 6% | Experimental | In the participants of this group, the tooth whitening process will be performed with 6% hydrogen peroxide. Receives: Procedure: Tooth Bleaching with Whiteness HP Automixx 6% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tooth color
The Vita Easyshade® digital spectrometer (VITA Zahnfabrik H. Rauter GmbH \& Co. KG, Germany) will be used for evaluation. The upper left canine will be used as a color reference because it is the most saturated tooth in the arch (greater dentin mass and greater amount of intrinsic pigments).
Measured: Baseline and 48 hours after each bleaching session.
Changes in tooth sensitivity
It will be explained to the participant that each face drawn in a figure represents a person who has no pain, or some, or a lot of pain. Face 0 doesn't hurt at all. Face 2 hurts a little. Face 4 hurts a little more. Face 6 hurts a lot. Face 8 hurts the most. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain. The participant will choose the face that best portrays the pain they are experiencing.
Measured: Baseline and 48 hours after each bleaching session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Mar 2025 (estimated)
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity, ToothStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789004
- Sponsor's protocol ID
- DeciduousBleaching
- Status last verified
- Oct 2024
- First submitted
- 16 Mar 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition: Study Protocol for a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05789004
- Acronym / sponsor ID
- DeciduousBleaching
- Conditions
- Sensitivity, Tooth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 29 Mar 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.
The aesthetics of dental elements generates great psychological and social impacts, both in the deciduous and permanent dentition. One of the techniques widely used to visually improve the appearance of teeth is bleaching. Bleaching can be performed both at home and in a dental office. In office whitening, the technique used consists of applying the whitening gel to the dental surfaces in concentrations ranging from 25% to 50% of hydrogen peroxide. However, recent studies show that low and medium concentration bleaching agents based on hydrogen peroxide have been effective and present a lower risk of sensitivity to the patient. In view of the above, this study aims to carry out a controlled and randomized clinical trial to compare the effectiveness of dental bleaching in deciduous teeth with hydrogen peroxide at concentrations of 35% and 6%. For this, 38 patients aged 03 to 06 years will be selected, allocated in 2 groups (G1 - Hydrogen Peroxide 35%, n=19 and G2- Hydrogen Peroxide 6%, n=19). Bleaching will be carried out in up to three sessions, with an interval of 7 days between them and the evaluation of color and tooth sensitivity will be carried out 48 hours after each bleaching session. The color assessment will be measured using a digital spectrometer and tooth sensitivity using the Pain Level Scale (Wong-Baker Faces®). Descriptive statistical analysis will be carried out, containing the mean and standard deviation in the calculation and normality and homogeneity tests will be carried out, for subsequent adequate statistical analysis. As a result, it is expected that there is no significant difference between the groups in terms of color variation and that the low-concentration bleaching group has the lowest sensitivity index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen Peroxide 35% | Experimental | Procedure: Tooth Bleaching with Whiteness HP Automixx 35%In the participants of this group, the tooth whitening process will be performed with 35% hydrogen peroxide. |
| Hydrogen Peroxide 6% | Experimental | Procedure: Tooth Bleaching with Whiteness HP Automixx 6%In the participants of this group, the tooth whitening process will be performed with 6% hydrogen peroxide. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age range from 03 to 06 years old;
- Vital or non-vital teeth (already endodontically treated) with severe to moderate discoloration;
- No active carious lesions;
- No lesions in the oral cavity;
- No report of previous tooth sensitivity.
Key exclusion criteria (1 listed)
- Patients who during anamnesis report allergies to dyes or latex, who withdraw from participating in the study, as well as those who do not attend the callbacks, will be excluded.
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 |
|---|---|---|
| Tooth Bleaching with Whiteness HP Automixx 35%* Clinical examination and taking the initial shade of the tooth with Vita Easyshade®; * Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®); * Prophylaxis with a Robson brush and prophylactic paste; * Application of lip balm on the patient's lips; * Placement of the labial retractor; * Application of the gingival barrier; * Application of Whiteness HP Automixx 35% whitening gel; * In the session, a single application of the gel will be carried out and where it will remain on the surface of the tooth for 15 min; * The gel must be removed from the teeth with a sucker and the teeth cleaned with gauze; * Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®); * The second bleaching session will be carried out 7 days after the first one and, if necessary, a third session can be carried out 7 days after the second one. | Procedure or surgery | Hydrogen Peroxide 35% |
| Tooth Bleaching with Whiteness HP Automixx 6%* Clinical examination and taking the initial shade of the tooth with Vita Easyshade®; * Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®); * Prophylaxis with a Robson brush and prophylactic paste; * Application of lip balm on the patient's lips; * Placement of the labial retractor; * Application of the gingival barrier; * Application of Whiteness HP Automixx 6% whitening gel; * In the session, a single application of the gel will be carried out and where it will remain on the surface of the tooth for 15 min; * The gel must be removed from the teeth with a sucker and the teeth cleaned with gauze; * Sensitivity/pain recording using the Pain Level Scale (Wong-Baker Faces®); * The second bleaching session will be carried out 7 days after the first one and, if necessary, a third session can be carried out 7 days after the second one. | Procedure or surgery | Hydrogen Peroxide 6% |
Primary outcome
Changes in tooth color
Time frame: Baseline and 48 hours after each bleaching session.
The Vita Easyshade® digital spectrometer (VITA Zahnfabrik H. Rauter GmbH \& Co. KG, Germany) will be used for evaluation. The upper left canine will be used as a color reference because it is the most saturated tooth in the arch (greater dentin mass and greater amount of intrinsic pigments).
Changes in tooth sensitivity
Time frame: Baseline and 48 hours after each bleaching session.
It will be explained to the participant that each face drawn in a figure represents a person who has no pain, or some, or a lot of pain. Face 0 doesn't hurt at all. Face 2 hurts a little. Face 4 hurts a little more. Face 6 hurts a lot. Face 8 hurts the most. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain. The participant will choose the face that best portrays the pain they are experiencing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tooth Bleaching with Whiteness HP Automixx 35% and Tooth Bleaching with Whiteness HP Automixx 6% in people with Sensitivity, Tooth, run by University of Nove de Julho.
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 1 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 4 Nov 2024. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Changes in tooth color (time frame: Baseline and 48 hours after each bleaching session.). 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?
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 2024.