NCT Number: NCT07464197
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Sant Cugat del Vallès, BARCELONA, 08195, Spain
Location status: Recruiting
LISSETHE PEÑATE, DDS, PhD
SUB_INVESTIGATOR
LISSETHE PEÑATE, Sub Investigator
CONTACT
MARTA VALLES, DDS, PhD
PRINCIPAL_INVESTIGATOR
MARTA VALLES, Principal Investigator
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: With reservoir, Without reservoir
At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol
Other names: 10% carbamide peroxide bleaching gel
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.
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.
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 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 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 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 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 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 (acceptance) with tooth color changes assessed using a Visual Analog Scale (VAS): 0 = least satisfaction, 10 = most satisfaction.
Contact information is provided by the study sponsor or research team.
LISSETHE PEÑATE, DDS, PhD
CONTACT
MARTA VALLES, DDS, PhD
CONTACT
Universitat Internacional de Catalunya
Other
Evaluation of the Effectiveness in Dental Bleaching by Different Designs of 3D-Printed Digital Customized Nightguards
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