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

Not Applicable

• Conditions: Tooth Discolouration

• Registration Number: NCT06881654
• Lead Sponsor: Universidad Rey Juan Carlos

Brief Summary

The aim of this clinical study is to evaluate patient satisfaction, bleaching efficacy, and the risk and severity of tooth sensitivity and gingival irritation during home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. A total of 100 patients will be selected to undergo home bleaching with either soft or rigid trays (n=50). Bleaching will be performed with 16% carbamide peroxide (Whiteness Perfect 16%, FGM, Joinville, SC, Brazil) for 2 hours daily for 3 weeks (21 days). Patient satisfaction will be assessed initially, weekly during the 3 weeks of treatment, and one month after completion of treatment using a questionnaire based on a visual analogue scale (VAS) from 0 to 10. Tooth colour will be assessed at baseline, 1 and 3 weeks during treatment, and 1, 6 and 12 months after treatment using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales (VITA Zahnfabrik, Bad Säckingen, Germany). The risk and intensity of tooth sensitivity and gingival irritation were recorded in a diary using a 0-10 VAS during treatment. Patient satisfaction data were analysed using Student's paired t-test. Colour change will be compared between groups using Student's t-test. The absolute risk of tooth sensitivity and gingival irritation was compared between groups using Fisher's exact test. Relative risk and confidence intervals (CI) were also calculated. The intensity of dental sensitivity and gingival irritation was analysed using Student's t-test for independent samples. The significance level will be set at 5% for all statistical tests.

Detailed Description

The purpose of this clinical trial is to evaluate patient satisfaction, whitening efficacy, and the risk and severity of tooth sensitivity and gingival irritation after home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. In addition, to assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide and finally to assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide.

Study Timeline

• Study Start: 2024-10-24
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dental Sensitivity Visual Analog Scale (VAS) 0-10	1 month	To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity, using a visual analogue scale of 0 to 10, when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Patient's oral quality of life Visual Analog Scale (VAS) 0-10	1 month	To assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale when using conventional (soft) trays or rigid trays for home bleaching with 16% carbamide peroxide.
Whitening Efficacy CIEL*a*b*	1 month	To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Gingival irritation VAS (0-10)	1 month	To assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale of 0 to 10 when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Alcorcón, Madrid, Spain