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Completed

NCT Number: NCT05955222

Clinical Performance of CAD/CAM Splint Materials

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.

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Key information

Conditions

TMD

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ıstanbul University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEK

Device

Participants receiving splints produced with CAD/CAM from PEEK blocks,

Other names: bite splints

PMMA

Device

Participants receiving splints produced with CAD/CAM from PMMA blocks,

Other names: PMMA splints

Traditional

Device

Participants receiving splints from vacuum forming system

Other names: traditional splints

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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