Clinical Performance of CAD/CAM Splint Materials

Istanbul University

Status: Completed

Conditions: TMD

Treatments: Device: PEEK; Device: PMMA; Device: Traditional

Study type: Interventional

Funder types: Other

Identifiers

NCT05955222

TDK-2020-35910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with TMD according to DC/TMD
• Aged between 18 and 65

Exclusion criteria

• Patients with removable dentures
• Patients diagnosed with Disc displacement without reduction according to DC/TMD
• Patients receiving medication for psychological disorders
• Patients diagnosed with systemic joint disorders
• Pregnant
• Patients who has received TMD treatment in the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

PEEK splint group

Experimental group

Description:

Patients received splints produced from PEEK blocks

Treatment:

Device: PEEK

PMMA splint group

Experimental group

Description:

Patients received splints produced from PMMA blocks

Treatment:

Device: PMMA

Traditional splint group

Active Comparator group

Description:

Patients received splints produced fabricated traditional methods (vacuum forming )

Treatment:

Device: Traditional