Clinical Performance of CAD/CAM Splint Materials

August 10, 2023 updated by: Bilge Gokcen-Rohlig, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • ıstanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEK splint group
Patients received splints produced from PEEK blocks
Device: PEEK
Participants receiving splints produced with CAD/CAM from PEEK blocks,
Other Names:
  • bite splints
Experimental: PMMA splint group
Patients received splints produced from PMMA blocks
Device: PMMA
Participants receiving splints produced with CAD/CAM from PMMA blocks,
Other Names:
  • PMMA splints
Active Comparator: Traditional splint group
Patients received splints produced fabricated traditional methods (vacuum forming )
Device: Traditional
Participants receiving splints from vacuum forming system
Other Names:
  • traditional splints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of occlusal surface change
Time Frame: Baseline and 6 months
Amount of material loss on the occlusal surface of the splints were determined by superimposition of the scannings which were obtained at the base line and at the end of the study. The surfaces were scanned with a professional reference scanner (Solutionix C500 Optical 3D Measuring System,2018,South Korea) and the data obtained were aligned for the best fit algorithm and digital evaluations were performed with the Geomagic Control (2021,USA) software program with an accuracy of 0.001 mm. Surface abrasions were determined by superposition at 24 different predetermined points.
Baseline and 6 months
Measurement of the opposing teeth hard tissue change
Time Frame: Baseline and 6 months
Hard tissue wear on opposing teeth were determined by superimposition of the casts of the patients which were obtained at the base line and at the end of the study. The cast models were scanned with a professional reference scanner (Solutionix C500 Optical 3D Measuring System,2018,South Korea) and the data obtained were aligned for the best fit algorithm. Evaluations were performed with the Geomagic Control (2021,USA) software program with an accuracy of 0.001 mm. Surface abrasions were determined by superposition at 30 different predetermined points.
Baseline and 6 months
Evaluation of the Fit of the splint
Time Frame: Baseline
The cameo surfaces of the splints were scanned for the evaluation of integral accuracy of the splints and superimposed with the Standard Triangle Language (STL) data of dental arch. The maxillary cast models and the cameo surface of the occlusal splints were scanned with a professional reference scanner (Solutionix C500 Optical 3D Measuring System,2018,South Korea) and the data obtained were aligned for the best fit algorithm. Fit evaluations were performed with the Geomagic Control (2021,USA) software program with an accuracy of 0.001 mm. Surface abrasions were determined by superposition at 24 different predetermined points.
Baseline
Pain change
Time Frame: baseline and 6 months
Patients were examined according to DC/TMD (Diagnostic Criteria/ Temporomandibular Disorders) protocol and Clinical examination form of the DC/TMD protocol was used. The patients were examined before and after the treatment. The pain scores of masticatory muscles as well as pain during mandibular movements were recorded.
baseline and 6 months
Subjective pain change
Time Frame: baseline and 6 months
Patient's evaluations of their overall pain were with performed with VAS (Visual analogue scale). VAS scores ranges from 0 to 100 with the leftmost point indicating 'very poor' and the rightmost 'very good'. The patients were asked to report their pain before and after the treatment.
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Chair: Bilge Gokcen Rohlig, Prof. Dr., Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2020

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

July 1, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDK-2020-35910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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