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

N/ACompletedNCT07208708

Universidad Rey Juan Carlos40 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Patient Satisfaction Bleaching Efficacy Tooth Sensitivity Gingival Irritation

Interventions

Scalloped margin retainerOTHER

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).

Straight orthodontic retainerOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks

Secondary Outcomes

Bleaching efficacy

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.

Time frame: 2 weeks

Tooth sensitivity

Was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicated no sensitivity and 10 indicated severe sensitivity

Time frame: 2 weeks

Gingival irritation

Was assessed using the same methodology as TS, with VAS ranging from 0 (no irritation) to 10 (severe irritation)

Time frame: 2 weeks

Data from ClinicalTrials.gov

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