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

U

Universidad Rey Juan Carlos

Status

Completed

Conditions

Tooth Sensitivity
Bleaching Efficacy
Gingival Irritation
Patient Satisfaction

Treatments

Other: Straight orthodontic retainer
Other: Scalloped margin retainer

Study type

Interventional

Funder types

Other

Identifiers

NCT07208708
URJC_IDIBO_4

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

40 participants in 2 patient groups

Scalloped margin retainer
Active Comparator group
Treatment:
Other: Scalloped margin retainer
Straight margin retainer
Experimental group
Treatment:
Other: Straight orthodontic retainer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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