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

24 de julio de 2026 actualizado por: Radboud University Medical Center

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

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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Población de estudio

The population for this prospective clinical randomized crossover trial, will consist of young adult participants aged 18 to 45, which study Dentistry, or are a co-worker or patient at the Dentistry Department of Radboudumc Nijmegen.

Descripción

Inclusion criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Sequence B
Participants receive a CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension (without a wax bite registration) for 3 weeks, followed by a CAD/CAM occlusal splint fabricated using a conventional wax bite registration for 3 weeks.
Dispositivo: 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).
Dispositivo: 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).
Experimental: Sequence A
Participants receive a CAD/CAM occlusal splint fabricated using a conventional wax bite registration for 3 weeks, followed by a CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension (without a wax bite registration) for 3 weeks.
Dispositivo: 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).
Dispositivo: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant-reported comfort
Periodo de tiempo: From enrollment to the end of treatment at 7 weeks
Self-reported wear comfort by filling in a questionnaire. This scale measures the comfort of the occlusal splint (0-10), where "very uncomfortable" represents the worst experience (lowest score) and "very comfortable" represents the best experience (highest score). Minimum Value: very uncomfortable, Maximum Value: very comfortable. Higher Scores Mean: better comfort (more comfort)
From enrollment to the end of treatment at 7 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Radboud University Medical Center

Investigadores

  • Investigador principal: Sabine Mechelse, MSc, Radboud University Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

31 de enero de 2027

Finalización del estudio (Estimado)

31 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

17 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2026

Publicado por primera vez (Actual)

22 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • R0147841A

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Specific IPD datasets, such as those underlying published results, will be shared. However, this sharing will occur under strict conditions to ensure data security and participant confidentiality. The data will be pseudonymized, using a secure key management system to separate identifiers from research data. Access will require appropriate agreements, ensuring compliance with ethical and legal standards, and will be granted only for research purposes aligning with the study's objectives.

Marco de tiempo para compartir IPD

Beginning 3 months and ending 3 years after the publication of results.

Criterios de acceso compartido de IPD

To ensure confidentiality and compliance, access to IPD will be restricted to authorized personnel involved in the research process, including the Principal Investigator (PI), specific research team members, external collaborators, and regulatory authorities. Access is based on each individual's role and necessity for the research. The PI will have full access to the IPD, pseudonymized data, and supporting documents for data management and reporting. Research team members, such as co- investigators, assistants, and statisticians, will have access to the data necessary for their assigned tasks. Access will be controlled through formal data requests, Data Use Agreements, and secure platforms. Pseudonymization ensures participant confidentiality while enabling the sharing of valuable research data for scientific progress.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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