At-home tooth bleaching with clear aligners
At-home Bleaching With the Use of Clear Aligners: Randomized Single-blind Equivalence Clinical Trial
This study is testing whether using clear aligners or traditional trays for at-home tooth bleaching helps people get whiter teeth and how it affects their comfort and satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universidad Rey Juan Carlos Academic / other |
| Locations | 1 site (Tafalla, Navarra) |
| Trial ID | NCT05835453 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of at-home tooth bleaching using 10% carbamide peroxide with either a conventional bleaching tray or a clear aligner. Forty patients will be randomly assigned to receive one of the two types of trays for a duration of 4 weeks, with assessments of tooth color, sensitivity, gingival irritation, and patient satisfaction conducted at multiple time points. The study will utilize both subjective color guides and objective digital spectrophotometry to measure outcomes, alongside visual analog scales for sensitivity and satisfaction. Statistical analyses will compare the results between the two groups to determine the most effective method.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with vital teeth in need of whitening and no significant dental restorations.
Not a fit: Patients with a history of previous whitening treatments, orthodontic work, or specific dental conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and comfortable method for at-home tooth whitening.
How similar studies have performed: Other studies have shown promising results with similar at-home bleaching approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria will be the following: * Patients over 18 years of age. * 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 rinses. Patients with recessions without sensitivity are included. * Absence of sensitivity, measured based on stimulation with the air from the syringe. * Patients who are at least in A2-A3 color (Vita Classic Guide) The exclusion criteria will be the following: * Patients who have previously undergone whitening (less than 5 years). * Patients undergoing orthodontic treatment. * Patients with white spot or developmental alterations (dentinogenesis imperfecta, amelogenesis imperfecta) or with stains (tetracyclines or fluorosis). * Patients with a history of trauma to anterior teeth. * Patients who require internal whitening. * Smokers. * Pregnant or lactating women. * Allergy to any component of whitening. * Alterations of the oral mucosa (desquamative gingivitis, OLP, leukoplakias, etc.). * 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.
Where this trial is running
Tafalla, Navarra
- Clínica Dental Iturralde — Tafalla, Navarra, Spain (Recruiting)
Study contacts
- Study coordinator: Isabel Giráldez, PhD
- Email: isabel.giraldez@urjc.es
- Phone: +34669119781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.