An interventional study of Customized bleaching tray fabrication and Reservoir tray design in Tooth Discoloration and Tooth Staining, sponsored by Universitat Internacional de Catalunya. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.
This study's planned enrollment of 40 is below the median of 48 across 97 interventional studies indexed under Tooth Discoloration.
Browse Tooth Discoloration studies →Universitat Internacional de Catalunya is the lead sponsor of 151 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Customized digital (3D-printed CAD-CAM) bleaching tray with reservoir design for at-home bleaching with 10% carbamide peroxide.
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.
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.
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.
Procedure: Customized bleaching tray fabrication · Procedure: Reservoir tray design · Drug: Carbamide peroxide 10%
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.
Also known as: Conventional vacuum-formed tray fabrication, Digital 3D-printed CAD-CAM tray fabrication
Tray designs were prepared either with a reservoir or without a reservoir, according to randomized allocation across hemiarches within the split-mouth design.
Also known as: With reservoir, Without reservoir
At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol
Also known as: 10% carbamide peroxide bleaching gel
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.
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 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.
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 (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.
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)
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.
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)
Gingival irritation presence assessed using a Numeric Rating Scale: 0 = absent, 1 = localized, 2 = generalized.
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)
Gingival irritation severity assessed using a Numeric Rating Scale: 0 = no irritation, 1 = gingival burning, 2 = erosion.
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)
Patient comfort assessed using a Visual Analog Scale (VAS): 0 = no comfort, 10 = high comfort.
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)
Patient satisfaction (acceptance) with tooth color changes assessed using a Visual Analog Scale (VAS): 0 = least satisfaction, 10 = most satisfaction.
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).
Plan to share: 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.
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for May 2026, 48 months after the start.
Of 44 non-industry interventional studies with no phase under Tooth Discoloration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 48 months is above that.
Counting every sponsor, half of 52 studies reached it within 8 months; a quarter within 2 and three quarters within 18.
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Studies of the drug tested here: Carbamide Peroxide
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