Customized bleaching 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 design: 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%: At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol
Study 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. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Primary outcome measure(s)
Tooth color change (spectrophotometer; ΔE*ab) — 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) — 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.
Trial sites (1)
Facility
City
Region
Status
Clínica Universitària d'Odontologia UIC Barcelona
Sant Cugat del Vallès
BARCELONA
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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