At-home Bleaching Using Clear Retainers

October 1, 2025 updated by: Isabel Giráldez de Luis, Universidad Rey Juan Carlos

PATIENT SATISFACTION WITH AT-HOME DENTAL BLEACHING USING VIVERA OR ESSIX RETAINERS: A RANDOMIZED CLINICAL TRIAL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarre
      • Tafalla, Navarre, Spain, 31300
        • Clínica Dental Iturralde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Essix-type retairner
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
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.
Active Comparator: Vivera retainer
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient´s satisfaction
Time Frame: Baseline, after one, two and four weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color change evaluation
Time Frame: Baseline, after one, two and four weeks
The color will be assesed using subjetive color guides (VITA Classical and VITA 3D-MASTER) and a objetive digital spectrophotometer (VITA Easyshade).
Baseline, after one, two and four weeks
Intensity and absolute risk of tooth sensitivity
Time Frame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
They will be determined by means of a visual analog scale (EVA), using a essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide.
Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Intensity and absolute risk of gingival irritation
Time Frame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
They will be determined by means of a visual analog scale (EVA), using a essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide.
Baseline, after one, two, four weeks, and at 1 month after bleaching treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Rey Juan Carlos

Collaborators

Align Technology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 10, 2024

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URJC_IDIBO_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingivitis

Clinical Trials on Whitening

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe