Patient Satisfaction With At-home Dental Bleaching Using Orthodontic Retainers With Different Margin Designs

Not Applicable

Completed

• Conditions: Patient Satisfaction; Bleaching Efficacy; Tooth Sensitivity; Gingival Irritation

• Registration Number: NCT07208708
• Lead Sponsor: Universidad Rey Juan Carlos

Brief Summary

This randomized single-blind, split-mouth clinical trial evaluated patient satisfaction with at-home dental bleaching using orthodontic retainers with different margin designs, as well as bleaching efficacy, tooth sensitivity (TS), and gingival irritation (GI).

Detailed Description

The objective of the study will be to clinically evaluate patient satisfaction, as well as the effectiveness of colour change, tooth sensitivity and gingival irritation with home whitening using 10% carbamide peroxide performed with orthodontic retainers with different cut-outs. Forty patients will be selected to receive home teeth whitening with a straight or scalloped retainer on each half-arch (n=40). The whitening procedure will be performed with 10% carbamide peroxide (Pola Night 10%) for 2 hours over 14 days. Patient satisfaction will be assessed weekly for two weeks through a series of questions using the Visual Analogue Scale (VAS 0-10). Colour will be assessed initially, weekly for two weeks and 1 month after completion of whitening, using the subjective VITA Classical scale, VITA Bleachedguide 3D-MASTER and the objective VITA Easyshade spectrophotometer. The intensity and risk of tooth sensitivity and gingival irritation will be recorded on the Visual Analogue Scale (VAS 0-10). Patient satisfaction will be assessed using the paired Student's t-test. The colour change between the groups will be compared using the paired Student's t-test. The absolute risk of tooth sensitivity and gingival irritation in both groups will be compared using the McNemar test. The intensity of tooth sensitivity and gingival irritation will be analysed using the Student's t-test for paired samples. The significance level will be 5% in all statistical tests.

Study Timeline

• Study Start: 2025-04-07
• Primary Completion: 2025-06-09
• Study Completion: 2025-07-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-28
• Study First Submitted QC: 2025-09-28
• Last Update Submitted: 2025-09-28
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06

Recruitment & Eligibility

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

Inclusion Criteria

• Completed of orthodontic treatment with Invisalign aligners (Align Technology Inc., CA, USA); willingness to undergo tooth bleaching as a complementary procedure; and current use of clear retainers. Additional criteria included age of ≥18 years of age, good general and oral health, and provision of informed consent. Eligible participants also needed anterior teeth free from carious and periodontal disease, with canines of shade A2 or darker on the VITA Classical scale (VITA Zahnfabrik, Bad Säckingen, Germany) and a Whiteness Index for Dentistry (WID) value ≤15.

Exclusion Criteria

• History of previous bleaching; self-reported tooth sensitivity; continuous use of analgesics or anti-inflammatory drugs; pregnancy or breastfeeding; and deleterious habits such as bruxism or smoking. Participants with anterior teeth presenting fixed orthodontic appliances, attachments, restorations, endodontic treatment, color changes due to tetracyclines or fluorosis, or visible enamel cracks were also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	2 weeks	Patient satisfaction was assessed daily using a Visual Analog Scale (VAS, 0-10) consisting of nine questions was provided to Participants completed a satisfaction diary independently throughout the 2-week bleaching period, without evaluator interference or time restrictions. The scale ranged from 0 (no problem/very good) to 10 (maximum problem/very bad), with participants marking a vertical line corresponding to their perception.

Secondary Outcome Measures

Name	Time	Method
Bleaching efficacy	2 weeks	Tooth color was evaluated at baseline and after treatment using both subjective and objective methods. Subjective evaluation was performed with the VITA Classical and VITA Bleachedguide 3D-MASTER shade guides. Objective evaluation was carried out with the VITA Easyshade spectrophotometer (Vita Zahnfabrik) using the CIELab\* color system.
Tooth sensitivity	2 weeks	Was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicated no sensitivity and 10 indicated severe sensitivity
Gingival irritation	2 weeks	Was assessed using the same methodology as TS, with VAS ranging from 0 (no irritation) to 10 (severe irritation)

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Alcorcón, Madrid, Spain