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

NCT ID: NCT07247760

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-27
• Study Completion Date: 2026-06-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whitening treatment for 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.

Group Type: EXPERIMENTAL

Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be over 18 years of age.
• Have white spots on teeth between 1.3 and 2.3 or between 3.3 and 4.3.
• No previous dental treatment on teeth affected by hypomineralisation lesions.
• No active caries lesions at any ICDAS II stage on the anterior teeth.
• Patients with satisfactory oral hygiene and periodontal health, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without sensitivity are included.

Exclusion Criteria

• Patients who have previously undergone whitening treatment (less than 5 years ago).
• Patients undergoing orthodontic treatment.
• Patients with a history of trauma to the front teeth.
• Patients with endodontically treated anterior teeth.
• Pregnant or breastfeeding patients.
• Patients who smoke.
• Patients with periodontal disease.
• Patients with poor oral hygiene.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Isabel Giráldez de Luis

PhD DDS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mª VICTORIA FUENTES, PhD Proffesor

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Countries

Spain

Other Identifiers

URJC_IDIBO_5

Identifier Type: -

Identifier Source: org_study_id