Clinical trial NCT05955222: Clinical Performance of CAD/CAM Splint Materials
Official title: Clinical Performance Comparison of Different Occlusal Splint Materials: a Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMD
Keywords: occlusal splint
CAD/CAM splint
clinical performance
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a prospective, randomized, double-blind in-vivo study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of occlusal surface change
timeFrame: Baseline and 6 months
measure: Measurement of the opposing teeth hard tissue change
timeFrame: Baseline and 6 months
measure: Evaluation of the Fit of the splint
timeFrame: Baseline
measure: Pain change
timeFrame: baseline and 6 months
measure: Subjective pain change
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: ıstanbul University
Study officials:
affiliation: Istanbul University
name: Bilge Gokcen Rohlig, Prof. Dr.
role: STUDY_CHAIR
References: