NCT07464197

Effectiveness of Dental Bleaching Using Different Designs of 3D-Printed and Conventional Customized Nightguards

Evaluation of the Effectiveness in Dental Bleaching by Different Designs of 3D-Printed Digital Customized Nightguards

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
DRUG	Carbamide peroxide 10%	At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol

Timeline

• Start date: 2022-05-01
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2026-03-11
• Last updated: 2026-03-16

Locations

1 site across 1 country: Spain