At-home Bleaching Using Clear Aligners

Sponsor

Universidad Rey Juan Carlos (Other)

Overall Status

Recruiting

CT.gov ID

NCT05835453

Collaborator

(none)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Discoloration Tooth Sensitivity Gingivitis Satisfaction, Patient	Other: Whitening	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

At-home Bleaching With the Use of Clear Aligners: Randomized Single-blind Equivalence Clinical Trial

Actual Study Start Date :

Apr 14, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional tray 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: conventional tray or clear aligner. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of the tray and the aligner: 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 tray, completing a total of 4 weeks of whitening procedure.
Active Comparator: Clear aligner 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 tray, completing a total of 4 weeks of whitening procedure.

Arm

Intervention/Treatment

Active Comparator: Conventional tray

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: conventional tray or clear aligner. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of the tray and the aligner: 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 tray, completing a total of 4 weeks of whitening procedure.

Active Comparator: Clear aligner

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

Outcome Measures

Primary Outcome Measures

Color change evaluation [Baseline, after one, two, four weeks, and at 1 month after bleaching treatment]
The color will be assessed using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade).

Secondary Outcome Measures

Intensity and absolute risk of tooth sensitivity [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 conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.
Intensity and absolute risk of gingival irritation [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 conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.
Patient´s satisfaction [Baseline, after one, two, four weeks, and at 1 month after bleaching treatment]
It will be measured with a questionnaire using a visual analog scale (EVA), when a conventional bleaching tray or a clear aligner is used to perform a at home bleaching treatment with 10% carbamide peroxide.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Participants will be recruited from those that attend Clínica Iturralde interested in a bleaching treatment as a complement to an orthodontic treatment with clear aligners. Patients will be 18 years old or older and those who meet the eligibility criteria, before being included in the study, will agree to participate and sign the informed consent form.

Inclusion criteria are adults with anterior vital teeth, free from caries lesions, restorative treatments, periodontal disease, endodontic treatment, with both maxillar canines presenting A2 or darker color according to the VITA Classical guide (VITA Zahnfabrik, Bad Säckingen, Germany), and 15 or less according to Whiteness Index (VitaEasyshade spectrophotometer, VITA) and in good general and oral health. Participants under chronic medication, with previous tooth bleaching, previous tooth sensitivity, with fixed orthodontic appliances (attachements) or prostheses, parafunction, gingival recession, discoloration due to fluorosis or tetracycline, pregnant or breastfeeding, with visible cracks in the teeth or smokers will be excluded.