At-home Bleaching Using Clear Retainers

Not Applicable

Completed

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

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

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.

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 Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Study Start: 2023-09-14
• Primary Completion: 2023-12-15
• Study Completion: 2024-12-10
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient´s satisfaction	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.

Secondary Outcome Measures

Name	Time	Method
Color change evaluation	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).
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 essix-type retairner or Vivera retainer, 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 essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide.

Trial Locations

Locations (1)

Clínica Dental Iturralde; 🇪🇸 Tafalla, Navarre, Spain