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Search / Trial NCT06881654

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

Launched by UNIVERSIDAD REY JUAN CARLOS · Mar 11, 2025

Trial Information

Current as of April 23, 2025

Enrolling by invitation

Keywords

Sensitivity Gingival Irritation Comfort Home Bleaching Soft Tray Rigid Tray

ClinConnect Summary

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 Cl...

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

LAURA CEBALLOS, PhD Proffesor

Study Chair

Universidad Rey Juan Carlos

Victoria Fuentes, PhD Reader

Study Director

Universidad Rey Juan Carlos

ISABEL GIRALDEZ, PhD Assistan Proffesor

Principal Investigator

Universidad Rey Juan Carlos

About Universidad Rey Juan Carlos

Universidad Rey Juan Carlos (URJC) is a prominent academic institution located in Madrid, Spain, dedicated to advancing knowledge and research in various fields, including health sciences. With a commitment to innovation and excellence, URJC actively engages in clinical trials aimed at improving patient care and outcomes. The university's multidisciplinary approach fosters collaboration among researchers, clinicians, and industry partners, ensuring that its clinical research is grounded in scientific rigor and ethical standards. Through its robust infrastructure and expertise, Universidad Rey Juan Carlos is poised to contribute significantly to the advancement of medical research and the development of novel therapeutic interventions.

Locations

Alcorcón, Madrid, Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported