Home teeth whitening with 3D-printed versus conventional custom nightguards

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

This test sees if at-home whitening with 10% carbamide peroxide works better or feels more comfortable when using 3D-printed custom nightguards compared with conventional vacuum-formed trays for adults with stained teeth.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitat Internacional de Catalunya (other)
• Locations: 1 site (Sant Cugat del Vallès, BARCELONA)
• Trial ID: NCT07464197 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, split-mouth trial gives each participant both digitally fabricated (3D-printed CAD-CAM) and conventional vacuum-formed custom nightguards, with and without reservoirs, so each person serves as their own control. Bleaching is performed at home using 10% carbamide peroxide and tooth color is measured by both visual shade guides and spectrophotometer with a customized positioner to standardize measurements. The study records tooth color change over time, tooth sensitivity, gingival irritation, patient comfort, and patient satisfaction. Adults in good general and oral health with front teeth shade A2 or darker are followed during and after treatment.

Who should consider this trial

Good fit: Adults in good general and oral health with at least six upper and six lower anterior teeth free of caries/restorations and maxillary central incisors of shade A2 or darker are the ideal candidates.

Not a fit: People with severe intrinsic staining, recent bleaching, orthodontic appliances or prostheses, pregnancy or lactation, or dental conditions linked to higher sensitivity are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, patients could achieve similar or improved whitening with more comfortable or easier-to-produce 3D-printed trays or with tray designs that reduce sensitivity.

How similar studies have performed: Previous smaller studies have compared CAD-CAM and conventional custom trays and generally found comparable whitening, but evidence specifically on reservoir design and 3D-printed trays is limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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)

Where this trial is running

Sant Cugat del Vallès, BARCELONA

• Clínica Universitària d'Odontologia UIC Barcelona — Sant Cugat del Vallès, BARCELONA, Spain (RECRUITING)

Study contacts

• Principal investigator: MARTA VALLES, DDS, PhD — Universitat Internacional de Catalunya
• Study coordinator: MARTA VALLES, DDS, PhD

Conditions: Tooth Discoloration, Tooth Staining, dental bleaching, custom tray, 3D-printed tray, CAD-CAM, Carbamide peroxide, Nightguard vital bleaching