Dental HypersensitivityNCT06035588
Effectiveness of 16% Carbamide Peroxide in Reducing Hypersensitivity During Alternate-day Home Bleaching
A study testing Daily whitening and Alternate whitening in people with Dental Hypersensitivity and Teeth Whitening, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster results, but instead patients may suffer more frequently from dental sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Hypersensitivity, Teeth Whitening
- What is being tested?
- Daily whitening and Alternate whitening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jan 2024to 1 Sep 2025
- 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
- Patients older than 18 years.
- Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth.
- Absence of cavities in the teeth to be whitened.
- Patients with satisfactory oral hygiene and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without presenting sensitivity will be included.
- Absence of sensitivity, measured with the application of air with the dental team's syringe.
- Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide).
Who cannot join
- Patients who have previously undergone whitening (less than 5 years).
- Patients undergoing orthodontic treatment.
- Patients with white spots or alterations in the development of enamel or with stains.
- Patients with a history of trauma to anterior teeth.
- Patients who require internal whitening.
- Smokers.
Show all 12Show fewer
- Pregnant or lactating.
- Patients with allergies to any whitening component.
- Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral lichen planus, leukoplakia, etc.).
- Patients with medical conditions considered by the researchers that may compromise the study or the individual safety of the patient.
- Patients with poor oral hygiene.
- Patients with previous hypersensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days: a Randomized Clinical Trial
The concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster results, but instead patients may suffer more frequently from dental sensitivity. The most commonly described side effect of all whitening procedures is the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this adverse effect.
The objective of the study is to clinically evaluate the difference in dental hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in a tray for two hours daily applied daily or every other day for three weeks.
Read the detailed description
Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching procedure will be performed every other day or daily. In the upper arch, the teeth to be whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and satisfaction will be carried out in the upper and lower arch. The color will be recorded before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade assessment using the subjective method will be recorded with the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the CIEL*a*b* system.
- Conditions
- Dental Hypersensitivity, Teeth Whitening
- Being tested
- Daily whitening, Alternate whitening
- Keywords
- bleaching, hipersensitivity, whitening, at-home, carbamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily whiteningOther
Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.
Alternate whiteningOther
Volunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study.
| Study group | Role | What they receive |
|---|---|---|
| Daily whitening | Active comparator | Volunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks. Receives: Other: Daily whitening |
| Alternate whitening | Experimental | Volunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours. Receives: Other: Alternate whitening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Sensitivity Visual Analog Scale (VAS) 0-10
The aim of this study is to clinically evaluate the incidence of tooth sensitivity induced by home whitening with 16% carbamide peroxide applied in a tray for two hours daily or every other day for three weeks. For the assessment, the operators will apply air to the cervical area of the upper and lower canines and ask the patient if he/she experienced sensitivity at any time during the treatment.
Measured: 3 weeks
Secondary outcomes (1)
Whitening Efficacy CIEL*a*b*
To assess whether the efficacy of the 16% carbamide peroxide bleaching treatment described above when used every other day is the same as when used every day, or whether there is a difference in bleaching efficacy. This will be determined at check-ups by measuring the upper and lower canines with the Vita EasyShade V® spectrophotometer, based on the CIEL*a*b* system, according to the CIELAB system, CIEDE2000 and the whiteness index. Where L* represents the value from 0 (black) to 100 (white) and a* and b* represent the colour, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis. In addition, the operators will take shade readings on all 4 canines using the VITA Classical and 3D-MASTER guides.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start6 Jan 2024
- Primary completion27 Feb 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental HypersensitivityStudies 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
- Model description
- Each volunteer will be given 3 syringes of 16% carbamide peroxide bleaching gel to use on the splint. Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the whitening procedure will be performed on alternate days or daily. In the upper arch, the teeth to be whitened will be from 15 to 25 and in the lower one from 35 to 45.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Giráldez de Luis, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035588
- Sponsor's protocol ID
- URJC University
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results obtained will only be shared once they have been published in an impact journal.
Publications
Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.
PubMed 20884923Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22.
PubMed 31335161de Geus JL, Wambier LM, Boing TF, Loguercio AD, Reis A. At-home Bleaching With 10% vs More Concentrated Carbamide Peroxide Gels: A Systematic Review and Meta-analysis. Oper Dent. 2018 Jul/Aug;43(4):E210-E222. doi: 10.2341/17-222-L.
PubMed 29949477
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06035588
- Acronym / sponsor ID
- URJC University
- Conditions
- Dental Hypersensitivity, Teeth Whitening
- Keywords
- bleaching, hipersensitivity, whitening, at-home, carbamide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 13 Sep 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 concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster results, but instead patients may suffer more frequently from dental sensitivity. The most commonly described side effect of all whitening procedures is the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this adverse effect.
The objective of the study is to clinically evaluate the difference in dental hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in a tray for two hours daily applied daily or every other day for three weeks.
Detailed description
Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching procedure will be performed every other day or daily. In the upper arch, the teeth to be whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and satisfaction will be carried out in the upper and lower arch. The color will be recorded before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade assessment using the subjective method will be recorded with the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the CIEL*a*b* system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each volunteer will be given 3 syringes of 16% carbamide peroxide bleaching gel to use on the splint. Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the whitening procedure will be performed on alternate days or daily. In the upper arch, the teeth to be whitened will be from 15 to 25 and in the lower one from 35 to 45.
| Arm | Type | Receives |
|---|---|---|
| Daily whitening | Active comparator | Other: Daily whiteningVolunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks. |
| Alternate whitening | Experimental | Other: Alternate whiteningVolunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 18 years.
- Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth.
- Absence of cavities in the teeth to be whitened.
- Patients with satisfactory oral hygiene and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without presenting sensitivity will be included.
- Absence of sensitivity, measured with the application of air with the dental team's syringe.
Key exclusion criteria (12 listed)
- Patients who have previously undergone whitening (less than 5 years).
- Patients undergoing orthodontic treatment.
- Patients with white spots or alterations in the development of enamel or with stains.
- Patients with a history of trauma to anterior teeth.
- Patients who require internal whitening.
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 |
|---|---|---|
| Daily whiteningDaily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity. | Other | Daily whitening |
| Alternate whiteningVolunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study. | Other | Alternate whitening |
Primary outcome
Dental Sensitivity Visual Analog Scale (VAS) 0-10
Time frame: 3 weeks
The aim of this study is to clinically evaluate the incidence of tooth sensitivity induced by home whitening with 16% carbamide peroxide applied in a tray for two hours daily or every other day for three weeks. For the assessment, the operators will apply air to the cervical area of the upper and lower canines and ask the patient if he/she experienced sensitivity at any time during the treatment.
1 secondary outcome
Whitening Efficacy CIEL*a*b*
Time frame: 1 month
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 2 Oct 2025.
- Background: PubMed 20884923Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.
- Background: PubMed 31335161Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22.
- Background: PubMed 29949477de Geus JL, Wambier LM, Boing TF, Loguercio AD, Reis A. At-home Bleaching With 10% vs More Concentrated Carbamide Peroxide Gels: A Systematic Review and Meta-analysis. Oper Dent. 2018 Jul/Aug;43(4):E210-E222. doi: 10.2341/17-222-L.
- Individual participant dataSharing planned: No. The results obtained will only be shared once they have been published in an impact journal.
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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 Daily whitening and Alternate whitening in people with Dental Hypersensitivity and Teeth Whitening, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 6 inclusion and 12 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 2 Oct 2025. 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 Spain. 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?
Dental Sensitivity Visual Analog Scale (VAS) 0-10 (time frame: 3 weeks). 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 NCT06035588, which also lists 3 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 2 Oct 2025.