Tooth DiscolorationNCT05835453
At-home Bleaching Using Clear Retainers
A study testing Whitening in people with Tooth Discoloration and Tooth Sensitivity, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The aim of this project is to clinically evaluate patient satisfaction, whitening efficacy, tooth sensitivity, and gingival irritation during at-home whitening with 10% carbamide peroxide using an Essix-type retainer or a Vivera retainer. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Tooth Sensitivity, Gingivitis
- What is being tested?
- Whitening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 14 Sep 2023to 10 Dec 2024
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria will be the following:
- Patients over 18 years of age.
- 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 rinses. Patients with recessions without sensitivity are included.
- Absence of sensitivity, measured based on stimulation with the air from the syringe.
- Patients who are at least in A2-A3 color (Vita Classic Guide)
The exclusion criteria will be the following:
- Patients who have previously undergone whitening (less than 5 years).
- Patients undergoing orthodontic treatment.
- Patients with white spot or developmental alterations (dentinogenesis imperfecta, amelogenesis imperfecta) or with stains (tetracyclines or fluorosis).
- Patients with a history of trauma to anterior teeth.
- Patients who require internal whitening.
- Smokers.
- Pregnant or lactating women.
- Allergy to any component of whitening.
- Alterations of the oral mucosa (desquamative gingivitis, OLP, leukoplakias, etc.).
- 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: PATIENT SATISFACTION WITH AT-HOME DENTAL BLEACHING USING VIVERA OR ESSIX RETAINERS: A RANDOMIZED CLINICAL TRIAL
The aim of this project is to clinically evaluate patient satisfaction, whitening efficacy, tooth sensitivity, and gingival irritation during at-home whitening with 10% carbamide peroxide using an Essix-type retainer or a Vivera retainer.
Read the detailed description
Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, essix-type retairner or Vivera retainer. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours The treatment lasted 4 weeks, although as each retainer was worn every other day, the actual application time was 2 weeks. Patient´s satisfaction will be evaluated at baseline, after one, two weeks, and 4 weeks with an apropriate questionnaire using a visual analog scale (EVA 0-10). The color will be assessed at baseline, after one, two and four weeks using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.
- Being tested
- Whitening
- Keywords
- At-home tooth bleaching, Clear aligner, Tooth sensitivity, Gingival irritation, Patient´s satisfaction
- Medical subject headings
- Tooth Discoloration, Dentin Sensitivity, Gingivitis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhiteningOther
Two syringes of 10% carbamide peroxide bleaching gel will be provided for use with each type of tray. Volunteers will be instructed to use the whitening gel once a day for 2 hours, for 3 days per week with each retainer, completing a total of 4 weeks of whitening procedure.
| Study group | Role | What they receive |
|---|---|---|
| Essix-type retairner | Active comparator | Two simple randomizations will be performed using a software program freely available online (www.sealedenvelop.com). For the first randomization, for each participant, the group (type of tray) will be randomized and it will always be applied to the participant's right hemiarch (n=40) according to the model: essix-type retairner or Vivera retainer. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of essix-type retairner and Vivera retainer: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. Receives: Other: Whitening |
| Vivera retainer | Active comparator | The patients will use the clear aligner on their right hemiarch and according to the second randomization it will be applied on Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. Receives: Other: Whitening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient´s satisfaction
It will be measured with a questionnaire using a visual analog scale (EVA), when a essix-type retairner or Vivera retainer is used to perform a at home bleaching treatment with 10% carbamide peroxide.
Measured: Baseline, after one, two and four weeks
Secondary outcomes (3)
Color change evaluation
The color will be assesed using subjetive color guides (VITA Classical and VITA 3D-MASTER) and a objetive digital spectrophotometer (VITA Easyshade).
Measured: Baseline, after one, two and four weeks
Intensity and absolute risk of tooth sensitivity
They will be determined by means of a visual analog scale (EVA), using a essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide.
Measured: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Intensity and absolute risk of gingival irritation
They will be determined by means of a visual analog scale (EVA), using a essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide.
Measured: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start14 Sep 2023
- Primary completion15 Dec 2023
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies 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
- Single group
- Model description
- This is a randomized, single blind (evaluators), split mouth and equivalence study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Align Technology, Inc.
- Responsible party
- Principal investigator, Isabel Giráldez de Luis, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835453
- Sponsor's protocol ID
- URJC_IDIBO_1
- Status last verified
- Oct 2025
- First submitted
- 18 Apr 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9.
PubMed 22408775Carneiro TS, Favoreto MW, Bernardi LG, Sutil E, Wendlinger M, Centenaro GG, Reis A, Loguercio AD. Gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: a randomized, single-blind clinical trial. Clin Oral Investig. 2022 Jun;26(6):4381-4390. doi: 10.1007/s00784-022-04401-4. Epub 2022 Feb 7.
PubMed 35128627
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATIENT SATISFACTION WITH AT-HOME DENTAL BLEACHING USING VIVERA OR ESSIX RETAINERS: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT05835453
- Acronym / sponsor ID
- URJC_IDIBO_1
- Keywords
- At-home tooth bleaching, Clear aligner, Tooth sensitivity, Gingival irritation, Patient´s satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Align Technology, Inc.
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 28 Apr 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 aim of this project is to clinically evaluate patient satisfaction, whitening efficacy, tooth sensitivity, and gingival irritation during at-home whitening with 10% carbamide peroxide using an Essix-type retainer or a Vivera retainer.
Detailed description
Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, essix-type retairner or Vivera retainer. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours The treatment lasted 4 weeks, although as each retainer was worn every other day, the actual application time was 2 weeks. Patient´s satisfaction will be evaluated at baseline, after one, two weeks, and 4 weeks with an apropriate questionnaire using a visual analog scale (EVA 0-10). The color will be assessed at baseline, after one, two and four weeks using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, single blind (evaluators), split mouth and equivalence study.
| Arm | Type | Receives |
|---|---|---|
| Essix-type retairner | Active comparator | Other: WhiteningTwo simple randomizations will be performed using a software program freely available online (www.sealedenvelop.com). For the first randomization, for each participant, the group (type of tray) will be randomized and it will always be applied to the participant's right hemiarch (n=40) according to the model: essix-type retairner or Vivera retainer. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of essix-type retairner and Vivera retainer: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. |
| Vivera retainer | Active comparator | Other: WhiteningThe patients will use the clear aligner on their right hemiarch and according to the second randomization it will be applied on Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| WhiteningTwo syringes of 10% carbamide peroxide bleaching gel will be provided for use with each type of tray. Volunteers will be instructed to use the whitening gel once a day for 2 hours, for 3 days per week with each retainer, completing a total of 4 weeks of whitening procedure. | Other | Essix-type retairner, Vivera retainer |
Primary outcome
Patient´s satisfaction
Time frame: Baseline, after one, two and four weeks
It will be measured with a questionnaire using a visual analog scale (EVA), when a essix-type retairner or Vivera retainer is used to perform a at home bleaching treatment with 10% carbamide peroxide.
3 secondary outcomes
Color change evaluation
Time frame: Baseline, after one, two and four weeks
Intensity and absolute risk of tooth sensitivity
Time frame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Intensity and absolute risk of gingival irritation
Time frame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
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 3 Oct 2025.
- Background: PubMed 22408775Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9.
- Background: PubMed 35128627Carneiro TS, Favoreto MW, Bernardi LG, Sutil E, Wendlinger M, Centenaro GG, Reis A, Loguercio AD. Gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: a randomized, single-blind clinical trial. Clin Oral Investig. 2022 Jun;26(6):4381-4390. doi: 10.1007/s00784-022-04401-4. Epub 2022 Feb 7.
- 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.
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 Whitening in people with Tooth Discoloration and Tooth Sensitivity, 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?
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 3 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?
Patient´s satisfaction (time frame: Baseline, after one, two and four 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 NCT05835453, which also lists 2 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 3 Oct 2025.