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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEK splint group | Experimental | Patients received splints produced from PEEK blocks |
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| PMMA splint group | Experimental | Patients received splints produced from PMMA blocks |
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| Traditional splint group | Active Comparator | Patients received splints produced fabricated traditional methods (vacuum forming ) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEK | Device | Participants receiving splints produced with CAD/CAM from PEEK blocks, |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bilge Gokcen Rohlig, Prof. Dr. | Istanbul University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ıstanbul University | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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The study is designed as a prospective, randomized, double-blind in-vivo study
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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.
| PMMA | Device | Participants receiving splints produced with CAD/CAM from PMMA blocks, |
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| Traditional | Device | Participants receiving splints from vacuum forming system |
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| 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 |