Status:
ENROLLING_BY_INVITATION
16% Carbamide Peroxide Home Bleaching: Soft vs. Rigid Tray in a Randomized Blinded Equivalence Trial
Lead Sponsor:
Universidad Rey Juan Carlos
Conditions:
Tooth Discolouration
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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% carbami...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06881654
Start Date
September 24 2024
End Date
December 17 2025
Last Update
October 2 2025
Active Locations (1)
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1
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain, 28922