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Clinical Performance of CAD/CAM Splint Materials

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT05955222
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
37.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PEEK
  • Device: PMMA
  • Device: Traditional
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study is designed as a prospective, randomized, double-blind in-vivo studyThe study is designed as a prospective, randomized, double-blind in-vivo study
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patients will not know which group they are assigned. Also the clinician who is going to make the examinations before and after the study will not be aware of groups.
Primary Purpose:
Treatment
Official Title:
Clinical Performance Comparison of Different Occlusal Splint Materials: a Clinical Study
Actual Study Start Date :
Feb 2, 2020
Actual Primary Completion Date :
Aug 30, 2022
Actual Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of occlusal surface change [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ıstanbul University Istanbul Turkey

    Sponsors and Collaborators

    • Istanbul University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bilge Gokcen Rohlig, Professor Dr., Istanbul University
    ClinicalTrials.gov Identifier:
    NCT05955222
    Other Study ID Numbers:
    • TDK-2020-35910
    First Posted:
    Jul 21, 2023
    Last Update Posted:
    Jul 21, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Bilge Gokcen Rohlig, Professor Dr., Istanbul University
    occlusal splint
    CAD/CAM splint
    clinical performance
    Additional relevant MeSH terms:
    Polymethyl Methacrylate

    Study Results

    No Results Posted as of Jul 21, 2023