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

Last updated: September 28, 2025
Sponsor: Universidad Rey Juan Carlos
Overall Status: Completed

Phase

N/A

Condition

Acute And Chronic Dental Pain

Treatment

Scalloped margin retainer

Straight orthodontic retainer

Clinical Study ID

NCT07208708
URJC_IDIBO_4
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • History of previous bleaching; self-reported tooth sensitivity; continuous use ofanalgesics or anti-inflammatory drugs; pregnancy or breastfeeding; and deleterioushabits such as bruxism or smoking. Participants with anterior teeth presenting fixedorthodontic appliances, attachments, restorations, endodontic treatment, colorchanges due to tetracyclines or fluorosis, or visible enamel cracks were alsoexcluded.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Scalloped margin retainer
Phase:
Study Start date:
April 07, 2025
Estimated Completion Date:
July 28, 2025

Study 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.

Connect with a study center

  • Universidad Rey Juan Carlos

    Alcorcón 3130564, Madrid 3117732 28922
    Spain

    Site Not Available

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