Tooth DiscolorationNCT07464197
Effectiveness of Dental Bleaching Using Different Designs of 3D-Printed and Conventional Customized Nightguards
A study testing Customized bleaching tray fabrication, Reservoir tray design and Carbamide peroxide 10% in people with Tooth Discoloration and Tooth Staining, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
This randomized, double-blind, split-mouth clinical trial evaluates the effectiveness of at-home dental bleaching using customized nightguards fabricated by digital (3D-printed CAD-CAM) and conventional methods, with and without reservoirs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Tooth Staining
- What is being tested?
- Customized bleaching tray fabrication, Reservoir tray design and Carbamide peroxide 10%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to Jul 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Good general and oral health
- No current medical treatment (self-reported)
- No need for surgical, endodontic, periodontal, or restorative dental treatment
- At least six upper and six lower anterior teeth free of caries and restorations
- Maxillary central incisors with baseline shade A2 or darker
- Willingness to follow the study protocol and use the study-provided oral hygiene products/instructions
Who cannot join
- Previous tooth bleaching treatment
- Orthodontic appliances or prostheses that interfere with treatment
- Severe intrinsic discoloration (e.g., tetracycline staining, fluorosis, or endodontically treated teeth with discoloration)
- Pregnancy or lactation
- Bruxism
- Gingival recession, dentin exposure, visible enamel cracks, or other conditions associated with increased sensitivity
- Use of anti-inflammatory or analgesic medication during the study period (according to protocol)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clínica Universitària d'Odontologia UIC Barcelona
Sant Cugat del Vallès, BARCELONA, 08195
MARTA VALLES, Principal Investigator, 619747903, mvalles@uic.es
LISSETHE PEÑATE, Sub Investigator, lissethe@uic.es
About this study
Official title: Evaluation of the Effectiveness in Dental Bleaching by Different Designs of 3D-Printed Digital Customized Nightguards
This randomized, double-blind, split-mouth clinical trial evaluates the effectiveness of at-home dental bleaching using customized nightguards fabricated by digital (3D-printed CAD-CAM) and conventional methods, with and without reservoirs. Adult participants with good general and oral health and a baseline tooth shade of A2 or darker undergo bleaching with 10% carbamide peroxide. Outcomes include tooth color change (subjective and spectrophotometric measures), tooth sensitivity, gingival irritation, patient comfort, and patient satisfaction over time.
Read the detailed description
This study compares the effectiveness of at-home dental bleaching using customized conventional vacuum-formed trays and digitally fabricated (3D-printed CAD-CAM) trays. It also compares tray designs with and without reservoirs using a randomized split-mouth design.
Each participant receives both tray fabrication approaches and both reservoir conditions, distributed according to randomized allocation. Bleaching is performed with 10% carbamide peroxide. Participants are followed during and after treatment to assess tooth color change, tooth sensitivity, gingival irritation, comfort, and satisfaction.
Tooth color is assessed using both visual and spectrophotometric methods. A customized positioner is used to standardize the measurement location throughout the study.
- Conditions
- Tooth Discoloration, Tooth Staining
- Being tested
- Customized bleaching tray fabrication, Reservoir tray design, Carbamide peroxide 10%
- Keywords
- dental bleaching, custom tray, 3D-printed tray, CAD-CAM, Carbamide peroxide, Nightguard vital bleaching, Tooth sensitivity, Gingival irritation, Spectrophotometer, Split-mouth trial, tooth whitening
- Medical subject headings
- Tooth Discoloration, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized bleaching tray fabricationProcedure or surgery
Also called Conventional vacuum-formed tray fabrication, Digital 3D-printed CAD-CAM tray fabrication
Customized bleaching trays were fabricated using either a conventional vacuum-forming technique or a digital CAD-CAM 3D-printing technique, according to randomized allocation within a split-mouth design.
Reservoir tray designProcedure or surgery
Also called With reservoir, Without reservoir
Tray designs were prepared either with a reservoir or without a reservoir, according to randomized allocation across hemiarches within the split-mouth design.
Carbamide peroxide 10%Drug
Also called 10% carbamide peroxide bleaching gel
At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol
| Study group | Role | What they receive |
|---|---|---|
| Digital tray with reservoir | Experimental | Customized digital (3D-printed CAD-CAM) bleaching tray with reservoir design for at-home bleaching with 10% carbamide peroxide. Receives: Procedure: Customized bleaching tray fabrication; Procedure: Reservoir tray design; Drug: Carbamide peroxide 10% |
| Digital tray without reservoir | Experimental | Customized digital (3D-printed CAD-CAM) bleaching tray without reservoir design for at-home bleaching with 10% carbamide peroxide. Receives: Procedure: Customized bleaching tray fabrication; Procedure: Reservoir tray design; Drug: Carbamide peroxide 10% |
| Conventional tray with reservoir | Experimental | Customized conventional vacuum-formed bleaching tray with reservoir design for at-home bleaching with 10% carbamide peroxide. Receives: Procedure: Customized bleaching tray fabrication; Procedure: Reservoir tray design; Drug: Carbamide peroxide 10% |
| Conventional tray without reservoir | Experimental | Customized conventional vacuum-formed bleaching tray without reservoir design for at-home bleaching with 10% carbamide peroxide. Receives: Procedure: Customized bleaching tray fabrication; Procedure: Reservoir tray design; Drug: Carbamide peroxide 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color change (spectrophotometer; ΔE*ab)
Tooth color measured with a spectrophotometer (VITA Easyshade) using CIE L*, a*, b* values. Color change will be calculated as ΔE*ab relative to baseline (T0). Measurements are standardized using a customized positioner. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Tooth shade change (VITA Bleachedguide 3D-MASTER; shade guide units)
Tooth shade assessed visually using the VITA Bleachedguide 3D-MASTER. Shade guide scores will be converted to numeric values and reported as change from baseline (T0) at each time point. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Secondary outcomes (6)
Tooth sensitivity (Numeric Rating Scale, 0-4)
Tooth sensitivity assessed using a 5-point Numeric Rating Scale (NRS): 0 = none, 1 = slight, 2 = moderate, 3 = considerable, 4 = severe. For each visit, the worst (highest) NRS value reported at that assessment point will be used for analysis. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Tooth sensitivity (Visual Analog Scale, 0-10)
Tooth sensitivity assessed using a 10-cm Visual Analog Scale (VAS) from 0 (no sensitivity) to 10 (severe sensitivity). For each visit, the highest VAS value reported at that assessment point will be used for analysis. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Gingival irritation presence (NRS, 0-2)
Gingival irritation presence assessed using a Numeric Rating Scale: 0 = absent, 1 = localized, 2 = generalized.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Gingival irritation severity (NRS, 0-2)
Gingival irritation severity assessed using a Numeric Rating Scale: 0 = no irritation, 1 = gingival burning, 2 = erosion.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Patient comfort (VAS, 0-10)
Patient comfort assessed using a Visual Analog Scale (VAS): 0 = no comfort, 10 = high comfort.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Patient satisfaction with tooth color change (VAS, 0-10)
Patient satisfaction (acceptance) with tooth color changes assessed using a Visual Analog Scale (VAS): 0 = least satisfaction, 10 = most satisfaction.
Measured: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 May 2022
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Model description
- This is a randomized split-mouth clinical trial. Each participant receives both tray fabrication methods (conventional vacuum-formed and digital 3D-printed CAD-CAM) in different arches, and both tray designs (with and without reservoirs) distributed across hemiarches according to randomized allocation. Therefore, within-participant comparisons are performed for tray fabrication method and reservoir presence.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Vallés Rodríguez, Universitat Internacional de Catalunya
- Investigators
- MARTA VALLES, DDS, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464197
- Sponsor's protocol ID
- REST-ECL-2021-06
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains potentially identifiable clinical information from a small sample treated at a single center, and no data-sharing plan was included in the original participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness in Dental Bleaching by Different Designs of 3D-Printed Digital Customized Nightguards
- ClinicalTrials.gov ID
- NCT07464197
- Acronym / sponsor ID
- REST-ECL-2021-06
- Conditions
- Tooth Discoloration, Tooth Staining
- Keywords
- dental bleaching, custom tray, 3D-printed tray, CAD-CAM, Carbamide peroxide, Nightguard vital bleaching, Tooth sensitivity, Gingival irritation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Mar 2026 (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.
This randomized, double-blind, split-mouth clinical trial evaluates the effectiveness of at-home dental bleaching using customized nightguards fabricated by digital (3D-printed CAD-CAM) and conventional methods, with and without reservoirs. Adult participants with good general and oral health and a baseline tooth shade of A2 or darker undergo bleaching with 10% carbamide peroxide. Outcomes include tooth color change (subjective and spectrophotometric measures), tooth sensitivity, gingival irritation, patient comfort, and patient satisfaction over time.
Detailed description
This study compares the effectiveness of at-home dental bleaching using customized conventional vacuum-formed trays and digitally fabricated (3D-printed CAD-CAM) trays. It also compares tray designs with and without reservoirs using a randomized split-mouth design.
Each participant receives both tray fabrication approaches and both reservoir conditions, distributed according to randomized allocation. Bleaching is performed with 10% carbamide peroxide. Participants are followed during and after treatment to assess tooth color change, tooth sensitivity, gingival irritation, comfort, and satisfaction.
Tooth color is assessed using both visual and spectrophotometric methods. A customized positioner is used to standardize the measurement location throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a randomized split-mouth clinical trial. Each participant receives both tray fabrication methods (conventional vacuum-formed and digital 3D-printed CAD-CAM) in different arches, and both tray designs (with and without reservoirs) distributed across hemiarches according to randomized allocation. Therefore, within-participant comparisons are performed for tray fabrication method and reservoir presence.
| Arm | Type | Receives |
|---|---|---|
| Digital tray with reservoir | Experimental | Procedure: Customized bleaching tray fabrication, Procedure: Reservoir tray design, Drug: Carbamide peroxide 10%Customized digital (3D-printed CAD-CAM) bleaching tray with reservoir design for at-home bleaching with 10% carbamide peroxide. |
| Digital tray without reservoir | Experimental | Procedure: Customized bleaching tray fabrication, Procedure: Reservoir tray design, Drug: Carbamide peroxide 10%Customized digital (3D-printed CAD-CAM) bleaching tray without reservoir design for at-home bleaching with 10% carbamide peroxide. |
| Conventional tray with reservoir | Experimental | Procedure: Customized bleaching tray fabrication, Procedure: Reservoir tray design, Drug: Carbamide peroxide 10%Customized conventional vacuum-formed bleaching tray with reservoir design for at-home bleaching with 10% carbamide peroxide. |
| Conventional tray without reservoir | Experimental | Procedure: Customized bleaching tray fabrication, Procedure: Reservoir tray design, Drug: Carbamide peroxide 10%Customized conventional vacuum-formed bleaching tray without reservoir design for at-home bleaching with 10% carbamide peroxide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older
- Good general and oral health
- No current medical treatment (self-reported)
- No need for surgical, endodontic, periodontal, or restorative dental treatment
- At least six upper and six lower anterior teeth free of caries and restorations
Key exclusion criteria (7 listed)
- Previous tooth bleaching treatment
- Orthodontic appliances or prostheses that interfere with treatment
- Severe intrinsic discoloration (e.g., tetracycline staining, fluorosis, or endodontically treated teeth with discoloration)
- Pregnancy or lactation
- Bruxism
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 |
|---|---|---|
| Customized bleaching tray fabricationAlso: Conventional vacuum-formed tray fabrication, Digital 3D-printed CAD-CAM tray fabricationCustomized bleaching trays were fabricated using either a conventional vacuum-forming technique or a digital CAD-CAM 3D-printing technique, according to randomized allocation within a split-mouth design. | Procedure or surgery | Conventional tray with reservoir, Conventional tray without reservoir, Digital tray with reservoir, Digital tray without reservoir |
| Reservoir tray designAlso: With reservoir, Without reservoirTray designs were prepared either with a reservoir or without a reservoir, according to randomized allocation across hemiarches within the split-mouth design. | Procedure or surgery | Conventional tray with reservoir, Conventional tray without reservoir, Digital tray with reservoir, Digital tray without reservoir |
| Carbamide peroxide 10%Also: 10% carbamide peroxide bleaching gelAt-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol | Drug | Conventional tray with reservoir, Conventional tray without reservoir, Digital tray with reservoir, Digital tray without reservoir |
Primary outcome
Tooth color change (spectrophotometer; ΔE*ab)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Tooth color measured with a spectrophotometer (VITA Easyshade) using CIE L*, a*, b* values. Color change will be calculated as ΔE*ab relative to baseline (T0). Measurements are standardized using a customized positioner. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.
Tooth shade change (VITA Bleachedguide 3D-MASTER; shade guide units)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Tooth shade assessed visually using the VITA Bleachedguide 3D-MASTER. Shade guide scores will be converted to numeric values and reported as change from baseline (T0) at each time point. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.
6 secondary outcomes
Tooth sensitivity (Numeric Rating Scale, 0-4)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Tooth sensitivity (Visual Analog Scale, 0-10)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Gingival irritation presence (NRS, 0-2)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Gingival irritation severity (NRS, 0-2)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Patient comfort (VAS, 0-10)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
Patient satisfaction with tooth color change (VAS, 0-10)
Time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).
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 16 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains potentially identifiable clinical information from a small sample treated at a single center, and no data-sharing plan was included in the original participant consent.
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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.
MARTA VALLES, DDS, PhD principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized bleaching tray fabrication, Reservoir tray design and Carbamide peroxide 10% in people with Tooth Discoloration and Tooth Staining, run by Universitat Internacional de Catalunya 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 7 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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?
Contact MARTA VALLES, DDS, PhD (+34619747903, mvalles@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth color change (spectrophotometer; ΔE*ab) (time frame: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).). 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 16 Mar 2026.