RecruitingNot ApplicableNCT07464197

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


Sponsor

Universitat Internacional de Catalunya

Enrollment

40 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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)

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Interventions

PROCEDURECustomized 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.

PROCEDUREReservoir 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.

DRUGCarbamide peroxide 10%

At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol


Locations(1)

Clínica Universitària d'Odontologia UIC Barcelona

Sant Cugat del Vallès, BARCELONA, Spain

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NCT07464197


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