TMDNCT05955222
Clinical Performance of CAD/CAM Splint Materials
A study testing PEEK, PMMA and Traditional in people with TMD, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TMD
- What is being tested?
- PEEK, PMMA and Traditional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2020to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with TMD according to DC/TMD
- Aged between 18 and 65
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 ?
Read more
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.
Read the 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.
- Conditions
- TMD
- Being tested
- PEEK, PMMA, Traditional
- Keywords
- occlusal splint, CAD/CAM splint, clinical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEKDevice
Also called bite splints
Participants receiving splints produced with CAD/CAM from PEEK blocks,
PMMADevice
Also called PMMA splints
Participants receiving splints produced with CAD/CAM from PMMA blocks,
TraditionalDevice
Also called traditional splints
Participants receiving splints from vacuum forming system
| Study group | Role | What they receive |
|---|---|---|
| PEEK splint group | Experimental | Patients received splints produced from PEEK blocks Receives: Device: PEEK |
| PMMA splint group | Experimental | Patients received splints produced from PMMA blocks Receives: Device: PMMA |
| Traditional splint group | Active comparator | Patients received splints produced fabricated traditional methods (vacuum forming ) Receives: Device: Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start2 Feb 2020
- Primary completion30 Aug 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a prospective, randomized, double-blind in-vivo study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Gokcen-Rohlig, Istanbul University
- Investigators
- Bilge Gokcen Rohlig, Prof. Dr., Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955222
- Sponsor's protocol ID
- TDK-2020-35910
- Status last verified
- Aug 2023
- First submitted
- 1 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Comparison of Different Occlusal Splint Materials: a Clinical Study
- ClinicalTrials.gov ID
- NCT05955222
- Acronym / sponsor ID
- TDK-2020-35910
- Conditions
- TMD
- Keywords
- occlusal splint, CAD/CAM splint, clinical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is designed as a prospective, randomized, double-blind in-vivo study
| Arm | Type | Receives |
|---|---|---|
| PEEK splint group | Experimental | Device: PEEKPatients received splints produced from PEEK blocks |
| PMMA splint group | Experimental | Device: PMMAPatients received splints produced from PMMA blocks |
| Traditional splint group | Active comparator | Device: TraditionalPatients received splints produced fabricated traditional methods (vacuum forming ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with TMD according to DC/TMD
- Aged between 18 and 65
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEKAlso: bite splintsParticipants receiving splints produced with CAD/CAM from PEEK blocks, | Device | PEEK splint group |
| PMMAAlso: PMMA splintsParticipants receiving splints produced with CAD/CAM from PMMA blocks, | Device | PMMA splint group |
| TraditionalAlso: traditional splintsParticipants receiving splints from vacuum forming system | Device | Traditional splint group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilge Gokcen Rohlig, Prof. Dr. study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK, PMMA and Traditional in people with TMD, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of occlusal surface change (time frame: Baseline and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.