NCT05955222

Clinical Performance of CAD/CAM Splint Materials

Clinical Performance Comparison of Different Occlusal Splint Materials: a Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to compare the performance of computer aided designed and computer aided manufactured (CAD/CAM) occlusal splints with splints produced with conventional methods. The main questions this clinical study aims to answer are: * Do CAD/CAM splints have the same therapeutic effect as the traditional splints ? * Do CAD/CAM splints demonstrate better surface wear and fit and lower wear in opposing jaw than traditional splints ? * Is objective pain evaluation of the patient better with CAD/CAM splints ? Participants were asked to use the splints for 6 months, 8 hours a day and come for follow-up appointments 3 times during this 6 month period: * Delivery appointment * First appointment: one week later after delivery appointment * Last appointment: 6 months after delivery appointment Researchers compared CAD/CAM groups with traditional group to see the clinical performance of the CAD/CAM groups.

Detailed description

24 patients applying to Istanbul University Faculty of Dentistry Department of Prosthodontics and diagnosed with Diagnostic Criteria/ Temporomandibular Disorders (DC/TMD) protocol were included in the study. The patients were randomly divided into 3 groups (n=8); PEEK group (PEEKG), PMMA group (PMMAG), and control group (CG). Dental stone casts of the upper and the lower jaws of the patients were obtained by condensation type silicone impression material and occlusal splints were fabricated in study groups with digital method (designed and milled, manufactured with CAD/CAM) either from PEEK blocks or PMMA blocks and in control group with traditional vacuum pressing machine and adapted by the clinician at chairside. The patients wore the splints for 6 months. Surface roughness, surface wear, fit of the splints and patient satisfaction as well as therapeutic effect of the splints were examined.

Conditions

• TMD

Interventions

Type	Name	Description
DEVICE	PEEK	Participants receiving splints produced with CAD/CAM from PEEK blocks,
DEVICE	PMMA	Participants receiving splints produced with CAD/CAM from PMMA blocks,
DEVICE	Traditional	Participants receiving splints from vacuum forming system

Timeline

• Start date: 2020-02-02
• Primary completion: 2022-08-30
• Completion: 2023-04-01
• First posted: 2023-07-21
• Last updated: 2023-08-15

Locations

1 site across 1 country: Turkey (Türkiye)