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

NCT07208708 | Completed

• 1 other identifier: URJC_IDIBO_4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Patient Satisfaction; Bleaching Efficacy; Tooth Sensitivity; Gingival Irritation

Keywords

dental bleaching; color change; hydrogen peroxide; clinical trials

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  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.

  2 weeks

Secondary Outcomes (3)

• Bleaching efficacy

  2 weeks

• Tooth sensitivity

  2 weeks

• Gingival irritation

  2 weeks

Study Arms (2)

Scalloped margin retainer

ACTIVE COMPARATOR

Other: Scalloped margin retainer

Straight margin retainer

EXPERIMENTAL

Other: Straight orthodontic retainer

Interventions

Scalloped margin retainer OTHER

Patient satisfaction was assessed during 2 weeks of whitening with a scalloped orthodontic retainer. Colour change, TS and IG were also measured. No studies have evaluated the effect of different margin designs in orthodontic retainers used in for tooth bleaching. Therefore, the present study aimed to clinically assess the impact of scalloped and straight margin design in orthodontic retainers employed for at-home bleaching, considering patient satisfaction, bleaching efficacy, tooth sensitivity (TS), and gingival irritation (GI).

Scalloped margin retainer

Straight orthodontic retainer OTHER

Patient satisfaction was assessed during two weeks of whitening with a straight orthodontic retainer. Colour change, TS and IG were also measured. No studies have evaluated the effect of different margin designs in orthodontic retainers used in for tooth bleaching. Therefore, the present study aimed to clinically assess the impact of scalloped and straight margin design in orthodontic retainers employed for at-home bleaching, considering patient satisfaction, bleaching efficacy, tooth sensitivity (TS), and gingival irritation (GI). The null hypotheses were that no significant differences would be observed in: (1) patient satisfaction, (2) bleaching efficacy, (3) tooth sensitivity, and (4) gingival irritation, when different margin designs are used in orthodontic retainers for at-home tooth bleaching.

Straight margin retainer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Patient Satisfaction; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD DDS

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: April 7, 2025
• Primary Completion: June 9, 2025
• Study Completion: July 28, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)