Clinical trial NCT05835453: At-home Bleaching Using Clear Aligners
Official title: At-home Bleaching With the Use of Clear Aligners: Randomized Single-blind Equivalence Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Discoloration
Tooth Sensitivity
Gingivitis
Satisfaction, Patient
Keywords: At-home tooth bleaching
Clear aligner
Tooth sensitivity
Gingival irritation
Patient´s satisfaction
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a randomized, single blind (evaluators), split mouth and equivalence study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Color change evaluation
timeFrame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Secondary outcomes:
measure: Intensity and absolute risk of tooth sensitivity
timeFrame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
measure: Intensity and absolute risk of gingival irritation
timeFrame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
measure: Patient´s satisfaction
timeFrame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Other outcomes:
Locations:
city: Tafalla
country: Spain
facility: Clínica Dental Iturralde
state: Navarra
Study officials:
References:
citation: Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9.
citation: Carneiro TS, Favoreto MW, Bernardi LG, Sutil E, Wendlinger M, Centenaro GG, Reis A, Loguercio AD. Gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: a randomized, single-blind clinical trial. Clin Oral Investig. 2022 Jun;26(6):4381-4390. doi: 10.1007/s00784-022-04401-4. Epub 2022 Feb 7.