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
Universitat Internacional de Catalunya
40 participants
May 1, 2022
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
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
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.
Tray designs were prepared either with a reservoir or without a reservoir, according to randomized allocation across hemiarches within the split-mouth design.
At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07464197