16% Carbamide Peroxide Home Bleaching: Soft vs. Rigid Tray in a Randomized Blinded Equivalence Trial

Официальное название

Home Bleaching With 16% Carbamide Peroxide Using Conventional (Soft) Tray or Rigid Tray: a Randomized Blinded Equivalence Clinical Trial.

Обзор

The aim of this clinical study is to evaluate patient satisfaction, bleaching efficacy, and the risk and severity of tooth sensitivity and gingival irritation during home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. A total of 100 patients will be selected to undergo home bleaching with either soft or rigid trays (n=50). Bleaching will be performed with 16% carbamide peroxide (Whiteness Perfect 16%, FGM, Joinville, SC, Brazil) for 2 hours daily for 3 weeks (21 days). Patient satisfaction will be assessed initially, weekly during the 3 weeks of treatment, and one month after completion of treatment using a questionnaire based on a visual analogue scale (VAS) from 0 to 10. Tooth colour will be assessed at baseline, 1 and 3 weeks during treatment, and 1, 6 and 12 months after treatment using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales (VITA Zahnfabrik, Bad Säckingen, Germany). The risk and intensity of tooth sensitivity and gingival irritation were recorded in a diary using a 0-10 VAS during treatment. Patient satisfaction data were analysed using Student's paired t-test. Colour change will be compared between groups using Student's t-test. The absolute risk of tooth sensitivity and gingival irritation was compared between groups using Fisher's exact test. Relative risk and confidence intervals (CI) were also calculated. The intensity of dental sensitivity and gingival irritation was analysed using Student's t-test for independent samples. The significance level will be set at 5% for all statistical tests.

Подробное описание

The purpose of this clinical trial is to evaluate patient satisfaction, whitening efficacy, and the risk and severity of tooth sensitivity and gingival irritation after home bleaching with 16% carbamide peroxide using conventional (soft) trays or rigid trays. In addition, to assess whether there is a difference in patient satisfaction using a 0-10 visual analogue scale with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To evaluate whether there is a difference in whitening efficacy using the VITA Easyshade V spectrophotometer and the VITA Classical and VITA Linearguide 3D-MASTER scales with conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide. To assess whether there is a difference in the absolute risk and intensity of tooth sensitivity using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide and finally to assess whether there is a difference in the absolute risk and intensity of gingival irritation using a visual analogue scale from 0 to 10 when using conventional (soft) splints or rigid splints during home bleaching with 16% carbamide peroxide.

Вмешательства

• Процедура Bleaching teeth
  Traditionally, home bleaching has been done with soft silicone trays. Patients now wear aligners, which are rigid trays used for orthodontic treatment. The use of rigid trays for home whitening has not been validated. The aim of this clinical trial is to analyse the effectiveness, comfort and sensitivity perceived by patients when whitening with 0.5 mm rigid aligners.

Первичные конечные точки

• Dental Sensitivity Visual Analog Scale (VAS) 0-10 [Срок оценки: 1 month]
• Patient's oral quality of life Visual Analog Scale (VAS) 0-10 [Срок оценки: 1 month]
• Whitening Efficacy CIEL*a*b* [Срок оценки: 1 month]
• Gingival irritation VAS (0-10) [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Patients over 18 years of age.
• Patients with vital teeth without restorations, single crowns, implants and/or bridges on the anterior teeth.
• Absence of dental caries in the teeth to be whitened.
• Patients with satisfactory oral hygiene and periodontal health, not undergoing periodontal maintenance and not using chlorhexidine mouthwashes. Patients with recession and no sensitivity were included.
• The absence of sensitivity was measured by applying air with the syringe of the dental equipment.
• Patients whose canines were at least A2-A3 in colour.

Критерии исключения

• Patients who have already undergone bleaching (less than 5 years).
• Patients undergoing orthodontic treatment.
• Patients with white stains or changes in enamel development or staining.
• Patients with a history of trauma to the anterior teeth.
• Patients requiring internal bleaching.
• Smokers.
• Pregnant or lactating mothers.
• Patients with allergy to any of the bleaching components.
• Patients with oral mucosal changes (desquamative gingivitis, oral lichen planus, leukoplakia, etc.).
• Patients with medical conditions considered by the investigators to compromise the safety of the study or the individual patient.
• Patients with poor oral hygiene.
• Patients with a history of hypersensitivity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad Rey Juan Carlos — Alcorcón

Публикации

• Levrini L, Paracchini L, Bakaj R, Diaconu A, Cortese S. Dental bleaching during orthodontic treatment with aligners. Int J Esthet Dent. 2020;15(1):44-54. PMID 31994535
• Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22. PMID 31335161
• Carneiro TS, Favoreto MW, Centenaro GG, Carneiro OS, Crovador CJ, Stanislawczuk R, Reis A, Loguercio AD. Does simultaneous versus individual-arch at-home dental bleaching regimen influence patient satisfaction? A randomized clinical trial. J Esthet Restor Dent. 2022 Dec;34(8):1263-1271. doi: 10.1111/jerd.12962. Epub 2022 Sep 20. PMID 36125103

Идентификаторы

NCT: NCT06881654 · URJC_IDIBO_3 · Research Ethics Committee

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗