Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®.

Study Overview
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Brief Summary
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To compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled.

Detailed Description
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Forty participants received two different occlusal devices from two different workflows (fully conventional and fully digital). Every splint was scanned before and after the occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were compared in a software Geomagic® Control X calculates and measures the distance from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment).

Official Title
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Comparative Study of the Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®.

Conditions
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Occlusal Splints

Intervention / Treatment
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* Other: Occlusal Splints Analogic-Analogic
* Other: Occlusal Splints Analogic-Digital
* Other: Occlusal Splints Digital-Digital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 to 70 years old. Patients who maintain until first molar in both arches. Patients who need occlusal splints due to bruxism. Exclusion Criteria: Pregnant patients. Patients with removable prostheses. Patients with fixed prostheses between six to six in both arches. Patients with partial edentulism, do not maintain until first molar in both arches. Patients with Temporomandibular Disorders (TMD): articular noises, pain on palpation, limited opening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This clinical study has three arms of equal size: occlusal splints made by conventional impression and conventional fabrication (Group 1), occlusal splints made by conventional impression and digital design and fabrication (Group 2), and occlusal splints performed by intra-oral scanner and digital design and fabrication (Group 3). Otherwise, the allocation of each subject to each group will be done at random by a list made with specialized software until the sample will be fulfilled when the patient is recruited.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Analogic-Analogic<br>Occlusal splints made by conventional impression and conventional fabrication. | Other: Occlusal Splints Analogic-Analogic<br>* Take a conventional impression to the patient and conventional fabrication of the splint.<br>|
| Active Comparator: Analogic-Digital<br>Occlusal splints made by conventional impression and digital design and fabrication. | Other: Occlusal Splints Analogic-Digital<br>* Take a conventional impression to the patient and digital fabrication of the splint.<br>|
| Active Comparator: Digital-Digital<br>Occlusal splints performed by intra-oral scanner and digital design and fabrication. | Other: Occlusal Splints Digital-Digital<br>* Take a digital impression to the patient and digital fabrication of the splint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric changes assessed in Root Mean Square (RMS) | The software of automatically graphical comparisons called Geomagic® Control X (Geomagic Inc., 3D Systems Inc., USA) will be used to calculate the accuracy by measuring the distance (positive or negative) from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment). This approach will give us the mean of the simple arithmetic difference. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Dentistry, Occlusal records, Intraoral scan