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

NCT06881654 | Enrolling By Invitation

• 2 other identifiers: URJC_IDIBO_3Research Ethics Committee
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Tooth Discolouration

Keywords

sensitivity; gingival irritation; comfort; home-bleaching; soft-tray; rigid tray

Outcome Measures

Primary Outcomes (4)

• Dental Sensitivity Visual Analog Scale (VAS) 0-10

  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.

  1 month

• Patient's oral quality of life Visual Analog Scale (VAS) 0-10

  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.

  1 month

• Whitening Efficacy CIEL*a*b*

  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.

  1 month

• Gingival irritation VAS (0-10)

  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.

  1 month

Study Arms (2)

SOFT-TRAY. Patients in this group will have the whitening gel applied using the splint

ACTIVE COMPARATOR

Participants will apply the 16% carbamide peroxide bleaching gel to a 1 mm soft ethylene vinyl acetate tray for 2 hours per day.

RIGID-TRAY. Patients in this group wear a 0.5 mm rigid tray.

OTHER

Patients in this group should have the 16% carbamide peroxide bleaching gel applied in a 0.5 mm rigid polyethylene terephthalate tray for 2 hours per day.

Procedure: Bleaching teeth

Interventions

Bleaching teeth PROCEDURE

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.

RIGID-TRAY. Patients in this group wear a 0.5 mm rigid tray.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (3)

• Levrini L, Paracchini L, Bakaj R, Diaconu A, Cortese S. Dental bleaching during orthodontic treatment with aligners. Int J Esthet Dent. 2020;15(1):44-54.

  PMID: 31994535 BACKGROUND

• Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22.

  PMID: 31335161 BACKGROUND

• Carneiro TS, Favoreto MW, Centenaro GG, Carneiro OS, Crovador CJ, Stanislawczuk R, Reis A, Loguercio AD. Does simultaneous versus individual-arch at-home dental bleaching regimen influence patient satisfaction? A randomized clinical trial. J Esthet Restor Dent. 2022 Dec;34(8):1263-1271. doi: 10.1111/jerd.12962. Epub 2022 Sep 20.

  PMID: 36125103 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration; Hypersensitivity

Interventions

Tooth Bleaching

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Esthetics, Dental; Dentistry

Study Officials

• LAURA CEBALLOS, PhD Proffesor

  Universidad Rey Juan Carlos

  STUDY CHAIR

• Victoria Fuentes, PhD Reader

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

• ISABEL GIRALDEZ, PhD Assistan Proffesor

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer PhD

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: September 24, 2024
• Primary Completion: July 27, 2025
• Study Completion: December 17, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)