Status:
COMPLETED
Effectiveness of 16% Carbamide Peroxide in Reducing Hypersensitivity During Alternate-day Home Bleaching
Lead Sponsor:
Universidad Rey Juan Carlos
Conditions:
Dental Hypersensitivity
Teeth Whitening
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster ...
Detailed Description
Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching procedure will be per...
Eligibility Criteria
Inclusion
- Patients older than 18 years.
- Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth.
- Absence of cavities in the teeth to be whitened.
- Patients with satisfactory oral hygiene and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without presenting sensitivity will be included.
- Absence of sensitivity, measured with the application of air with the dental team's syringe.
- Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide).
Exclusion
- Patients who have previously undergone whitening (less than 5 years).
- Patients undergoing orthodontic treatment.
- Patients with white spots or alterations in the development of enamel or with stains.
- Patients with a history of trauma to anterior teeth.
- Patients who require internal whitening.
- Smokers.
- Pregnant or lactating.
- Patients with allergies to any whitening component.
- Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral lichen planus, leukoplakia, etc.).
- Patients with medical conditions considered by the researchers that may compromise the study or the individual safety of the patient.
- Patients with poor oral hygiene.
- Patients with previous hypersensitivity.
Key Trial Info
Start Date :
January 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06035588
Start Date
January 6 2024
End Date
September 1 2025
Last Update
October 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Isabel Giraldez de Luis
Alcorcón, Madrid, Spain, 28922