Tooth DiscolourationRigid trayNCT06881654
16% Carbamide Peroxide Home Bleaching: Soft vs. Rigid Tray in a Randomized Blinded Equivalence Trial
A study testing Bleaching teeth in people with Tooth Discolouration, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The aim of this clinical study is to evaluate patient satisfaction, bleaching efficacy, and the risk and severity of tooth sensitivity and gingival irritation during home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Discolouration
- What is being tested?
- Bleaching teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 24 Sep 2024to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Patients with vital teeth without restorations, single crowns, implants and/or bridges on the anterior teeth.
- Absence of dental caries in the teeth to be whitened.
- Patients with satisfactory oral hygiene and periodontal health, not undergoing periodontal maintenance and not using chlorhexidine mouthwashes. Patients with recession and no sensitivity were included.
- The absence of sensitivity was measured by applying air with the syringe of the dental equipment.
- Patients whose canines were at least A2-A3 in colour.
Who cannot join
- Patients who have already undergone bleaching (less than 5 years).
- Patients undergoing orthodontic treatment.
- Patients with white stains or changes in enamel development or staining.
- Patients with a history of trauma to the anterior teeth.
- Patients requiring internal bleaching.
- Smokers.
Show all 12Show fewer
- Pregnant or lactating mothers.
- Patients with allergy to any of the bleaching components.
- Patients with oral mucosal changes (desquamative gingivitis, oral lichen planus, leukoplakia, etc.).
- Patients with medical conditions considered by the investigators to compromise the safety of the study or the individual patient.
- Patients with poor oral hygiene.
- Patients with a history of hypersensitivity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Home Bleaching With 16% Carbamide Peroxide Using Conventional (Soft) Tray or Rigid Tray: a Randomized Blinded Equivalence Clinical Trial.
The aim of this clinical study is to evaluate patient satisfaction, bleaching efficacy, and the risk and severity of tooth sensitivity and gingival irritation during home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. A total of 100 patients will be selected to undergo home bleaching with either soft or rigid trays (n=50). Bleaching will be performed with 16% carbamide peroxide (Whiteness Perfect 16%, FGM, Joinville, SC, Brazil) for 2 hours daily for 3 weeks (21 days). Patient satisfaction will be assessed initially, weekly during the 3 weeks of treatment, and one month after completion of treatment using a questionnaire based on a visual analogue scale (VAS) from 0 to 10. Tooth colour will be assessed at baseline, 1 and 3 weeks during treatment, and 1, 6 and 12 months after treatment using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales (VITA Zahnfabrik, Bad Säckingen, Germany). The risk and intensity of tooth sensitivity and gingival irritation were recorded in a diary using a 0-10 VAS during treatment. Patient satisfaction data were analysed using Student's paired t-test. Colour change will be compared between groups using Student's t-test. The absolute risk of tooth sensitivity and gingival irritation was compared between groups using Fisher's exact test. Relative risk and confidence intervals (CI) were also calculated. The intensity of dental sensitivity and gingival irritation was analysed using Student's t-test for independent samples. The significance level will be set at 5% for all statistical tests.
Read the detailed description
The purpose of this clinical trial is to evaluate patient satisfaction, whitening efficacy, and the risk and severity of tooth sensitivity and gingival irritation after home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. In addition, to assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide and finally to assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide.
- Conditions
- Tooth Discolouration
- Being tested
- Bleaching teeth
- Keywords
- sensitivity, gingival irritation, comfort, home-bleaching, soft-tray, rigid tray
- Medical subject headings
- Tooth Discoloration, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleaching teethProcedure or surgery
Traditionally, home bleaching has been done with soft silicone trays. Patients now wear aligners, which are rigid trays used for orthodontic treatment. The use of rigid trays for home whitening has not been validated. The aim of this clinical trial is to analyse the effectiveness, comfort and sensitivity perceived by patients when whitening with 0.5 mm rigid aligners.
| Study group | Role | What they receive |
|---|---|---|
| SOFT-TRAY. Patients in this group will have the whitening gel applied using the splint | Active comparator | Participants will apply the 16% carbamide peroxide bleaching gel to a 1 mm soft ethylene vinyl acetate tray for 2 hours per day. |
| RIGID-TRAY. Patients in this group wear a 0.5 mm rigid tray. | Other | Patients in this group should have the 16% carbamide peroxide bleaching gel applied in a 0.5 mm rigid polyethylene terephthalate tray for 2 hours per day. Receives: Procedure: Bleaching teeth |
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
To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity, using a visual analogue scale of 0 to 10, when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Measured: 1 month
Patient's oral quality of life Visual Analog Scale (VAS) 0-10
To assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale when using conventional (soft) trays or rigid trays for home bleaching with 16% carbamide peroxide.
Measured: 1 month
Whitening Efficacy CIEL*a*b*
To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Measured: 1 month
Gingival irritation VAS (0-10)
To assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale of 0 to 10 when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
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 posted18 Mar 2025
- Study start24 Sep 2024
- Primary completion27 Jul 2025
- Study completion17 Dec 2025 (estimated)
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 Tooth DiscolourationStudies 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
- 100 participants (estimated)
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
- Investigators
- LAURA CEBALLOS, PhD Proffesor, Study chair, Universidad Rey Juan CarlosVictoria Fuentes, PhD Reader, Study director, Universidad Rey Juan CarlosISABEL GIRALDEZ, PhD Assistan Proffesor, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881654
- Sponsor's protocol ID
- URJC_IDIBO_3
- Other IDs
- Research Ethics Committee
- Acronym
- Rigid tray
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients have signed a consent form in which they give their data to the Universidad Rey Juan Carlos, but not to the entire research community. The results obtained will be shared, but not the personal data of the participants, in accordance with the regulations on the protection of personal data, specifically the European Regulation 679/2016, of 27 April, on General Data Protection, as well as the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights.
Publications
Levrini L, Paracchini L, Bakaj R, Diaconu A, Cortese S. Dental bleaching during orthodontic treatment with aligners. Int J Esthet Dent. 2020;15(1):44-54.
PubMed 31994535Chagas 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 31335161Carneiro TS, Favoreto MW, Centenaro GG, Carneiro OS, Crovador CJ, Stanislawczuk R, Reis A, Loguercio AD. Does simultaneous versus individual-arch at-home dental bleaching regimen influence patient satisfaction? A randomized clinical trial. J Esthet Restor Dent. 2022 Dec;34(8):1263-1271. doi: 10.1111/jerd.12962. Epub 2022 Sep 20.
PubMed 36125103
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
- Home Bleaching With 16% Carbamide Peroxide Using Conventional (Soft) Tray or Rigid Tray: a Randomized Blinded Equivalence Clinical Trial.
- ClinicalTrials.gov ID
- NCT06881654
- Acronym / sponsor ID
- Rigid tray / URJC_IDIBO_3
- Conditions
- Tooth Discolouration
- Keywords
- sensitivity, gingival irritation, comfort, home-bleaching, soft-tray, rigid tray
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 27 Jul 2025 (actual)
- Study completion
- 17 Dec 2025 (estimated)
- First posted
- 18 Mar 2025 (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 aim of this clinical study is to evaluate patient satisfaction, bleaching efficacy, and the risk and severity of tooth sensitivity and gingival irritation during home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. A total of 100 patients will be selected to undergo home bleaching with either soft or rigid trays (n=50). Bleaching will be performed with 16% carbamide peroxide (Whiteness Perfect 16%, FGM, Joinville, SC, Brazil) for 2 hours daily for 3 weeks (21 days). Patient satisfaction will be assessed initially, weekly during the 3 weeks of treatment, and one month after completion of treatment using a questionnaire based on a visual analogue scale (VAS) from 0 to 10. Tooth colour will be assessed at baseline, 1 and 3 weeks during treatment, and 1, 6 and 12 months after treatment using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales (VITA Zahnfabrik, Bad Säckingen, Germany). The risk and intensity of tooth sensitivity and gingival irritation were recorded in a diary using a 0-10 VAS during treatment. Patient satisfaction data were analysed using Student's paired t-test. Colour change will be compared between groups using Student's t-test. The absolute risk of tooth sensitivity and gingival irritation was compared between groups using Fisher's exact test. Relative risk and confidence intervals (CI) were also calculated. The intensity of dental sensitivity and gingival irritation was analysed using Student's t-test for independent samples. The significance level will be set at 5% for all statistical tests.
Detailed description
The purpose of this clinical trial is to evaluate patient satisfaction, whitening efficacy, and the risk and severity of tooth sensitivity and gingival irritation after home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. In addition, to assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide and finally to assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOFT-TRAY. Patients in this group will have the whitening gel applied using the splint | Active comparator | –Participants will apply the 16% carbamide peroxide bleaching gel to a 1 mm soft ethylene vinyl acetate tray for 2 hours per day. |
| RIGID-TRAY. Patients in this group wear a 0.5 mm rigid tray. | Other | Procedure: Bleaching teethPatients in this group should have the 16% carbamide peroxide bleaching gel applied in a 0.5 mm rigid polyethylene terephthalate tray for 2 hours per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years of age.
- Patients with vital teeth without restorations, single crowns, implants and/or bridges on the anterior teeth.
- Absence of dental caries in the teeth to be whitened.
- Patients with satisfactory oral hygiene and periodontal health, not undergoing periodontal maintenance and not using chlorhexidine mouthwashes. Patients with recession and no sensitivity were included.
- The absence of sensitivity was measured by applying air with the syringe of the dental equipment.
Key exclusion criteria (12 listed)
- Patients who have already undergone bleaching (less than 5 years).
- Patients undergoing orthodontic treatment.
- Patients with white stains or changes in enamel development or staining.
- Patients with a history of trauma to the anterior teeth.
- Patients requiring internal bleaching.
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 |
|---|---|---|
| Bleaching teethTraditionally, home bleaching has been done with soft silicone trays. Patients now wear aligners, which are rigid trays used for orthodontic treatment. The use of rigid trays for home whitening has not been validated. The aim of this clinical trial is to analyse the effectiveness, comfort and sensitivity perceived by patients when whitening with 0.5 mm rigid aligners. | Procedure or surgery | RIGID-TRAY. Patients in this group wear a 0.5 mm rigid tray. |
Primary outcome
Dental Sensitivity Visual Analog Scale (VAS) 0-10
Time frame: 1 month
To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity, using a visual analogue scale of 0 to 10, when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Patient's oral quality of life Visual Analog Scale (VAS) 0-10
Time frame: 1 month
To assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale when using conventional (soft) trays or rigid trays for home bleaching with 16% carbamide peroxide.
Whitening Efficacy CIEL*a*b*
Time frame: 1 month
To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Gingival irritation VAS (0-10)
Time frame: 1 month
To assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale of 0 to 10 when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 31994535Levrini L, Paracchini L, Bakaj R, Diaconu A, Cortese S. Dental bleaching during orthodontic treatment with aligners. Int J Esthet Dent. 2020;15(1):44-54.
- 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 36125103Carneiro TS, Favoreto MW, Centenaro GG, Carneiro OS, Crovador CJ, Stanislawczuk R, Reis A, Loguercio AD. Does simultaneous versus individual-arch at-home dental bleaching regimen influence patient satisfaction? A randomized clinical trial. J Esthet Restor Dent. 2022 Dec;34(8):1263-1271. doi: 10.1111/jerd.12962. Epub 2022 Sep 20.
- Individual participant dataSharing planned: No. The patients have signed a consent form in which they give their data to the Universidad Rey Juan Carlos, but not to the entire research community. The results obtained will be shared, but not the personal data of the participants, in accordance with the regulations on the protection of personal data, specifically the European Regulation 679/2016, of 27 April, on General Data Protection, as well as the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights.
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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.
LAURA CEBALLOS, PhD Proffesor study chair
Universidad Rey Juan Carlos
Victoria Fuentes, PhD Reader study director
Universidad Rey Juan Carlos
ISABEL GIRALDEZ, PhD Assistan Proffesor principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bleaching teeth in people with Tooth Discolouration, 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: enrolling by invitation, 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?
This study is still under way. Results are not available in the source record yet.
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: 1 month). The study lists 4 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 NCT06881654, 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.