At-home Bleaching Using Clear Retainers

NCT05835453 | Completed

• 1 other identifier: URJC_IDIBO_1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Discoloration; Tooth Sensitivity; Gingivitis; Satisfaction, Patient

Keywords

At-home tooth bleaching; Clear aligner; Tooth sensitivity; Gingival irritation; Patient´s satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient´s satisfaction

  It will be measured with a questionnaire using a visual analog scale (EVA), when a essix-type retairner or Vivera retainer is used to perform a at home bleaching treatment with 10% carbamide peroxide.

  Baseline, after one, two and four weeks

Secondary Outcomes (3)

• Color change evaluation

  Baseline, after one, two and four weeks

• Intensity and absolute risk of tooth sensitivity

  Baseline, after one, two, four weeks, and at 1 month after bleaching treatment

• Intensity and absolute risk of gingival irritation

  Baseline, after one, two, four weeks, and at 1 month after bleaching treatment

Study Arms (2)

Essix-type retairner

ACTIVE COMPARATOR

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.

Other: Whitening

Vivera retainer

ACTIVE COMPARATOR

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.

Other: Whitening

Interventions

Whitening OTHER

Two syringes of 10% carbamide peroxide bleaching gel will be provided for use with each type of tray. Volunteers will be instructed to use the whitening gel once a day for 2 hours, for 3 days per week with each retainer, completing a total of 4 weeks of whitening procedure.

Essix-type retairner; Vivera retainer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Align Technology, Inc.: collaborator

Study Sites (1)

Clínica Dental Iturralde

Tafalla, Navarre, 31300, Spain

Location

Related Publications (2)

• 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.

  PMID: 22408775 BACKGROUND

• 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.

  PMID: 35128627 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration; Dentin Sensitivity; Gingivitis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It will be a single-blind study in which only the evaluator will not know the designation of the groups because he has not participated in the study's randomization and implementation process. Due to the tray test and demonstration of the bleaching procedure, the operator and the participant cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a randomized, single blind (evaluators), split mouth and equivalence study.

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: September 14, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 10, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)