16% Carbamide Peroxide Home Bleaching: Soft vs. Rigid Tray in a Randomized Blinded Equivalence Trial

Launched by UNIVERSIDAD REY JUAN CARLOS · Mar 11, 2025

Keywords

ClinConnect Summary

This study is comparing two at-home tooth whitening methods using the same whitening gel (16% carbamide peroxide): a soft tray versus a rigid tray. Researchers want to know if the two tray types give similar whitening results and are equally comfortable, especially in terms of tooth sensitivity and gum irritation, and overall patient satisfaction. About 100 adults will be randomly assigned to one of the two tray types, with the person checking the results not knowing which tray was used.

Who can join? Adults 18 and older with healthy front teeth (no cavities or major dental work on the teeth to be whitened), good oral hygiene, and not currently undergoing orthodontic treatment or pregnant. People who have smoked recently, had whitening in the last five years, or have some dental conditions that could raise safety concerns probably won’t be eligible. If you participate, you’ll wear the assigned tray and use the whitening gel for 2 hours a day over 3 weeks. You’ll answer weekly questions about satisfaction, have tooth color measured at several time points (baseline, during treatment, and after up to 12 months), and keep a diary about any tooth sensitivity or gum irritation. The study is being done at Universidad Rey Juan Carlos in Alcorcón, Madrid, Spain, and is currently enrolling by invitation, with an estimated completion around April 2025. Personal data will be protected, and results will be shared without exposing individual information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients over 18 years of age.
• • Patients with vital teeth without restorations, single crowns, implants and/or bridges on the anterior teeth.
• • Absence of dental caries in the teeth to be whitened.
• • Patients with satisfactory oral hygiene and periodontal health, not undergoing periodontal maintenance and not using chlorhexidine mouthwashes. Patients with recession and no sensitivity were included.
• • The absence of sensitivity was measured by applying air with the syringe of the dental equipment.
• • Patients whose canines were at least A2-A3 in colour.
• Exclusion Criteria:
• • Patients who have already undergone bleaching (less than 5 years).
• • Patients undergoing orthodontic treatment.
• • Patients with white stains or changes in enamel development or staining.
• • Patients with a history of trauma to the anterior teeth.
• • Patients requiring internal bleaching.
• • Smokers.
• • Pregnant or lactating mothers.
• • Patients with allergy to any of the bleaching components.
• • Patients with oral mucosal changes (desquamative gingivitis, oral lichen planus, leukoplakia, etc.).
• • Patients with medical conditions considered by the investigators to compromise the safety of the study or the individual patient.
• • Patients with poor oral hygiene.
• • Patients with a history of hypersensitivity.