At-home Bleaching Using Clear Retainers

Universidad Rey Juan Carlos

Status: Completed

Conditions: Tooth Sensitivity; Tooth Discoloration; Satisfaction, Patient; Gingivitis

Treatments: Other: Whitening

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05835453

URJC_IDIBO_1

Details and patient eligibility

About

The aim of this project is to clinically evaluate patient satisfaction, whitening efficacy, tooth sensitivity, and gingival irritation during at-home whitening with 10% carbamide peroxide using an Essix-type retainer or a Vivera retainer.

Full description

Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, essix-type retairner or Vivera retainer. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours The treatment lasted 4 weeks, although as each retainer was worn every other day, the actual application time was 2 weeks. Patient´s satisfaction will be evaluated at baseline, after one, two weeks, and 4 weeks with an apropriate questionnaire using a visual analog scale (EVA 0-10). The color will be assessed at baseline, after one, two and four weeks 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). 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Essix-type retairner

Active Comparator group

Description:

Two simple randomizations will be performed using a software program freely available online (www.sealedenvelop.com). For the first randomization, for each participant, the group (type of tray) will be randomized and it will always be applied to the participant's right hemiarch (n=40) according to the model: essix-type retairner or Vivera retainer. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of essix-type retairner and Vivera retainer: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday.

Treatment:

Other: Whitening

Vivera retainer

Active Comparator group

Description:

The patients will use the clear aligner on their right hemiarch and according to the second randomization it will be applied on Monday, Wednesday and Friday or Tuesday, Thursday and Saturday.

Treatment:

Other: Whitening