Effectiveness of Dental Bleaching Using Different Designs of 3D-Printed and Conventional Customized Nightguards

Официальное название

Evaluation of the Effectiveness in Dental Bleaching by Different Designs of 3D-Printed Digital Customized Nightguards

Обзор

This randomized, double-blind, split-mouth clinical trial evaluates the effectiveness of at-home dental bleaching using customized nightguards fabricated by digital (3D-printed CAD-CAM) and conventional methods, with and without reservoirs. Adult participants with good general and oral health and a baseline tooth shade of A2 or darker undergo bleaching with 10% carbamide peroxide. Outcomes include tooth color change (subjective and spectrophotometric measures), tooth sensitivity, gingival irritation, patient comfort, and patient satisfaction over time.

Подробное описание

This study compares the effectiveness of at-home dental bleaching using customized conventional vacuum-formed trays and digitally fabricated (3D-printed CAD-CAM) trays. It also compares tray designs with and without reservoirs using a randomized split-mouth design.

Each participant receives both tray fabrication approaches and both reservoir conditions, distributed according to randomized allocation. Bleaching is performed with 10% carbamide peroxide. Participants are followed during and after treatment to assess tooth color change, tooth sensitivity, gingival irritation, comfort, and satisfaction.

Tooth color is assessed using both visual and spectrophotometric methods. A customized positioner is used to standardize the measurement location throughout the study.

Вмешательства

• Процедура Customized bleaching tray fabrication
  Customized bleaching trays were fabricated using either a conventional vacuum-forming technique or a digital CAD-CAM 3D-printing technique, according to randomized allocation within a split-mouth design.
• Процедура Reservoir tray design
  Tray designs were prepared either with a reservoir or without a reservoir, according to randomized allocation across hemiarches within the split-mouth design.
• Препарат Carbamide peroxide 10%
  At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol

Первичные конечные точки

• Tooth color change (spectrophotometer; ΔE*ab) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]
• Tooth shade change (VITA Bleachedguide 3D-MASTER; shade guide units) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]

Вторичные конечные точки (6)

• Tooth sensitivity (Numeric Rating Scale, 0-4) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]
• Tooth sensitivity (Visual Analog Scale, 0-10) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]
• Gingival irritation presence (NRS, 0-2) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]
• Gingival irritation severity (NRS, 0-2) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]
• Patient comfort (VAS, 0-10) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]
• Patient satisfaction with tooth color change (VAS, 0-10) [Срок оценки: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).]

Критерии участия

Критерии включения

• Adults aged 18 years or older
• Good general and oral health
• No current medical treatment (self-reported)
• No need for surgical, endodontic, periodontal, or restorative dental treatment
• At least six upper and six lower anterior teeth free of caries and restorations
• Maxillary central incisors with baseline shade A2 or darker
• Willingness to follow the study protocol and use the study-provided oral hygiene products/instructions

Критерии исключения

• Previous tooth bleaching treatment
• Orthodontic appliances or prostheses that interfere with treatment
• Severe intrinsic discoloration (e.g., tetracycline staining, fluorosis, or endodontically treated teeth with discoloration)
• Pregnancy or lactation
• Bruxism
• Gingival recession, dentin exposure, visible enamel cracks, or other conditions associated with increased sensitivity
• Use of anti-inflammatory or analgesic medication during the study period (according to protocol)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Clínica Universitària d'Odontologia UIC Barcelona — Sant Cugat del Vallès

Идентификаторы

NCT: NCT07464197 · REST-ECL-2021-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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