At-home Bleaching Using Clear Aligners

Gingivitis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dentin Sensitivity
• Gingivitis
• Hypersensitivity
• Satisfaction, Patient
• Tooth Discoloration
• Tooth Sensitivity

• NCT number: NCT05835453
• Study type: Interventional
• Source: Universidad Rey Juan Carlos
• Contact: Isabel Giráldez, PhD
• Phone: +34669119781
• Email: isabel.giraldez@urjc.es
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2023
• Completion date: June 10, 2024