At-home Bleaching Using Clear Aligners

Not Applicable

Recruiting

• Conditions: Tooth Sensitivity; Tooth Discoloration; Satisfaction, Patient; Gingivitis
• Interventions: Other: Whitening

• Registration Number: NCT05835453
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Study Timeline

• Study Start: 2023-04-14
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clear aligner	Whitening	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.
Conventional tray	Whitening	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Clínica Dental Iturralde; 🇪🇸 Tafalla, Navarra, Spain