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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mvalles@uic.es
• Phone: +34619747903

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.