Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults

Официальное название

Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without Wax Bite Registration: A Randomized Crossover Clinical Trial

Обзор

Occlusal splints are commonly used to manage sleep bruxism, temporomandibular disorders, and tooth wear. Traditionally, a wax bite registration is used during the fabrication of CAD/CAM occlusal splints to determine the vertical dimension and occlusal relationship. New digital techniques allow the splint to be designed without a wax bite registration by virtually increasing the vertical dimension based on maximal intercuspation. This randomized crossover study compares these two fabrication workflows in healthy volunteers. Participants will wear both splints in random order. The study will evaluate patient-reported comfort and clinical performance, including occlusal contacts, force distribution, splint stability, and the occlusal adjustments required during insertion

Подробное описание

Occlusal splints are widely used in the management of sleep bruxism, temporomandibular disorders, and tooth wear. The increasing implementation of CAD/CAM technology has improved the efficiency and reproducibility of occlusal splint fabrication. Conventionally, the vertical dimension and occlusal relationship are determined using a wax bite registration. Recent developments in digital dentistry now allow the vertical dimension to be increased virtually based on the patient's maximal intercuspation, eliminating the need for an additional wax bite registration.

Although both fabrication workflows are currently used in clinical practice, there is limited clinical evidence comparing their performance. It remains unclear whether omitting the conventional wax bite registration affects the initial clinical performance of CAD/CAM occlusal splints at insertion, before any occlusal adjustments are performed. Potential differences may exist in patient comfort, splint stability, occlusal contacts, force distribution, and the number of occlusal adjustments required. In addition, little is known about differences in patient-reported outcomes, including comfort, perceived occlusion, stability, and overall satisfaction during the period of splint use.

Вмешательства

• Устройство Occlusal splint fabricated using a virtual increase of the vertical dimension
  Intervention 1: CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension CAD/CAM-milled occlusal splint fabricated from PMMA using a fully digital workflow. The splint is designed by virtually increasing the vertical dimension based on the participant's maximal intercuspation, without the use of a conventional wax bite registration. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).
• Устройство Occlusal splint fabricated using a conventional wax bite registration
  Intervention 2: CAD/CAM occlusal splint fabricated using a conventional wax bite registration CAD/CAM-milled occlusal splint fabricated from the same PMMA material using a conventional wax bite registration to determine the vertical dimension and occlusal relationship during the digital design process. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).

Первичные конечные точки

• Participant-reported comfort [Срок оценки: From enrollment to the end of treatment at 7 weeks]

Критерии участия

Критерии включения

• Subjects aged 18-45 years
• Subjects with an ASA physical status classification of I-III.
• Subjects with healthy complete dentitions (except for congenitally missing teeth (agenesis), extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)
• Subjects willing and able to participate in the study
• Subjects willing to provide written informed consent for their participation in the study

Критерии исключения

• Subjects presenting with active dental disease, extensive restorations affecting the occlusion, or other oral conditions that may interfere with the assessment of the occlusal splints
• Subjects with a history of autoimmune disorders
• Subjects with known allergies to acrylic materials
• Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment
• Subjects who are pregnant or lactating
• Subjects enrolled in another investigational clinical trial

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• RadboudUMC — Nijmegen

Идентификаторы

NCT: NCT07720453 · R0147841A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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