Bleaching teeth: Traditionally, home bleaching has been done with soft silicone trays. Patients now wear aligners, which are rigid trays used for orthodontic treatment. The use of rigid trays for home whitening has not been validated. The aim of this clinical trial is to analyse the effectiveness, comfort and sensitivity perceived by patients when whitening with 0.5 mm rigid aligners.
Study 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 peroxide using conventional (soft) trays or rigid trays. A total of 100 patients will be selected to undergo home bleaching with either soft or rigid trays (n=50). Bleaching will be performed with 16% carbamide peroxide (Whiteness Perfect 16%, FGM, Joinville, SC, Brazil) for 2 hours daily for 3 weeks (21 days). Patient satisfaction will be assessed initially, weekly during the 3 weeks of treatment, and one month after completion of treatment using a questionnaire based on a visual analogue scale (VAS) from 0 to 10. Tooth colour will be assessed at baseline, 1 and 3 weeks during treatment, and 1, 6 and 12 months after treatment using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales (VITA Zahnfabrik, Bad Säckingen, Germany). The risk and intensity of tooth sensitivity and gingival irritation were recorded in a diary using a 0-10 VAS during treatment. Patient satisfaction data were analysed using Student's paired t-test. Colour change will be compared between groups using Student's t-test. The absolute risk of tooth sensitivity and gingival irritation was compared between groups using Fisher's exact test. Relative risk and confidence intervals (CI) were also calculated. The intensity of dental sensitivity and gingival irritation was analysed using Student's t-test for independent samples. The significance level will be set at 5% for all statistical tests.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dental Sensitivity Visual Analog Scale (VAS) 0-10 — 1 month To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity, using a visual analogue scale of 0 to 10, when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Patient's oral quality of life Visual Analog Scale (VAS) 0-10 — 1 month To assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale when using conventional (soft) trays or rigid trays for home bleaching with 16% carbamide peroxide.
Whitening Efficacy CIEL*a*b* — 1 month To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
Gingival irritation VAS (0-10) — 1 month To assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale of 0 to 10 when using conventional (soft) trays or rigid trays during home bleaching with 16% carbamide peroxide.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
