Clinical Performance of CAD/CAM Splint Materials

NCT05955222 | Completed DMC

• 1 other identifier: TDK-2020-35910
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

TMD

Keywords

occlusal splint; CAD/CAM splint; clinical performance

Outcome Measures

Primary Outcomes (5)

• Measurement of occlusal surface change

  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

  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

  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

  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

  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

Study Arms (3)

PEEK splint group

EXPERIMENTAL

Patients received splints produced from PEEK blocks

Device: PEEK

PMMA splint group

EXPERIMENTAL

Patients received splints produced from PMMA blocks

Device: PMMA

Traditional splint group

ACTIVE COMPARATOR

Patients received splints produced fabricated traditional methods (vacuum forming )

Device: Traditional

Interventions

PEEK DEVICE

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

Also known as: bite splints

PEEK splint group

PMMA DEVICE

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

Also known as: PMMA splints

PMMA splint group

Traditional DEVICE

Participants receiving splints from vacuum forming system

Also known as: traditional splints

Traditional splint group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

ıstanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Occlusal Splints

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Bilge Gokcen Rohlig, Prof. Dr.

  Istanbul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Model Details: The study is designed as a prospective, randomized, double-blind in-vivo study

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 21, 2023
• Study Start: February 2, 2020
• Primary Completion: August 30, 2022
• Study Completion: April 1, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)