At-home Bleaching Using Clear Aligners

Last updated: September 12, 2023
Sponsor: Universidad Rey Juan Carlos
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy (Pediatric)

Allergy

Periodontitis

Treatment

Whitening

Clinical Study ID

NCT05835453
IGiraldezdeLuis
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of the present project is to clinically evaluate the bleaching effectiveness, tooth sensitivity, gingival irritation and patient´s satisfaction during a at-home bleaching with 10% carbamide peroxide using a conventional bleaching tray or a clear aligner.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Whitening
Phase:
Study Start date:
April 14, 2023
Estimated Completion Date:
June 10, 2024

Study Description

Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, conventional or clear aligner. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours for 4 weeks. The color will be assessed at baseline, after one, two, four weeks, and at 1 month after bleaching treatment using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Patient´s satisfaction will be evaluated at baseline, after one and two weeks, and at 1 month after bleaching treatment with an apropriate questionnaire using a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.

Connect with a study center

  • Clínica Dental Iturralde

    Tafalla, Navarra 31300
    Spain

    Active - Recruiting

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