NCT07247760

PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE

PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE: CLINICAL TRIAL

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Universidad Rey Juan Carlos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial aims to evaluate patient satisfaction and the efficacy of home whitening with 10% carbamide peroxide in masking white spot lesions, as well as the presence of sensitivity and gingival irritation.

Detailed description

The clinical trial aims to evaluate patient satisfaction and the efficacy of home whitening with 10% carbamide peroxide in masking white spot lesions, as well as the presence of sensitivity and gingival irritation. Patients with at least one white spot due to enamel development defects in any of the anterior teeth will be selected, up to a minimum of 67 lesions. An initial characterisation of the white spot lesions will be performed using different standardised photographs with cross-polarisation filters, fluorescence and transillumination. In addition, mapping will be performed using a spectrophotometer to record the L\*a\*b\* parameters in the lesions and surrounding tissue, and patients will initially respond to a survey on their satisfaction with the lesions (VAS scale) and their impact on psychosocial well-being and oral health-related quality of life (PIDAQ and OHIP-14, respectively). Patients classified for the study will be whitened with 10% carbamide peroxide for 3 hours a day for 4 weeks, or until the desaturation obtained is to their liking, or until the CIELAB L\* parameter measurements indicate stabilisation of brightness using the spectrophotometer. During treatment, the presence of sensitivity and irritation will be recorded using a VAS scale. Patients will be reviewed 4 weeks after the end of treatment and will respond again to the questionnaire on satisfaction, psychosocial impact of dental aesthetics and oral quality of life (PIDAQ and OHIP-14), and the lesions will be characterised again. The data obtained on satisfaction, PIDAQ and OHIP-14 surveys will be statistically analysed, as will the colour difference between the lesions and the surrounding tissue enamel at the end of treatment.

Conditions

• White Spot Lesions

Interventions

Type	Name	Description
OTHER	Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions	Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions. Assess patient satisfaction with the masking of white spot lesions and the occurrence of tooth sensitivity and gingival irritation.

Timeline

• Start date: 2025-10-27
• Primary completion: 2026-03-02
• Completion: 2026-06-01
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: Spain