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

NCT07464197 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-16

No results posted yet for this 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.

Conditions

  • Tooth Discoloration
  • Tooth Staining

Interventions

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

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • MARTA VALLES, DDS, PhD · Universitat Internacional de Catalunya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2026-05-31
Completion
2026-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464197 on ClinicalTrials.gov