3D Printed vs. Milled Occlusal Splints in Dentistry

Официальное название

Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications

Обзор

This crossover study aims to evaluate the wear comfort, retention, and stability of 3D-printed and milled occlusal splints in healthy subjects. The main question it aims to answer is: Research questions \- How do healthy subjects experience the wear comfort, fitting, retention and stability of a printed and milled occlusal splint? and how do clinicians experience the fitting, retention and stability of the splints? By systematically assessing self-reported outcomes, this research seeks to contribute valuable insights into the practical applications of both technologies. The findings may not only enhance our understanding of patient preferences but also guide future developments in the design and manufacturing of occlusal splints, ultimately improving patient care in dental practice.

Подробное описание

The main study parameter is to assess the participant self-reported findings regarding the comfort, retention, stability and fit of the milled and printed splint and in addition to the hygiene and discoloration of the splint over time.

Первичные конечные точки

• Comfort [Срок оценки: "From enrollment to the end of treatment at 6 weeks"]

Вторичные конечные точки (7)

• Stability [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Perceived Retention of Occlusal Splint on Model [Срок оценки: From enrollment to end of treatment at six weeks]
• Perceived Retention of Occlusal Splint During Wear [Срок оценки: From enrollment to the end of treatment at six weeks.]
• Perceived Fit of the Occlusal Splint on the Model and in the Mouth [Срок оценки: From enrollment to end of the treatment at six weeks.]
• Perceived Fit of the Occlusal Splint on Teeth [Срок оценки: From enrollment to end of the treatment at six weeks]
• Cleanability [Срок оценки: From enrollment to the end of treatment at 6 weeks.]
• Occlusion [Срок оценки: From enrollment to the end of treatment at 6 weeks.]

Критерии участия

Критерии включения

• Subjects being healthy (ASA <IV)
• Subjects with healthy, complete dentitions (except for 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 with dental issues other than the inclusion criteria
• Subjects with a history of autoimmune disorder
• 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

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07236294 · 2024-17704

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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