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

Not Applicable

Completed

• Conditions: Occlusal Splints
• Interventions: Other: Occlusal Splints Analogic-Analogic; Other: Occlusal Splints Analogic-Digital; Other: Occlusal Splints Digital-Digital

• Registration Number: NCT05317182
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

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

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).

Study Timeline

• Study Start: 2022-02-17
• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-07
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Analogic-Analogic	Occlusal Splints Analogic-Analogic	Occlusal splints made by conventional impression and conventional fabrication.
Analogic-Digital	Occlusal Splints Analogic-Digital	Occlusal splints made by conventional impression and digital design and fabrication.
Digital-Digital	Occlusal Splints Digital-Digital	Occlusal splints performed by intra-oral scanner and digital design and fabrication.

Primary Outcome Measures

Name	Time	Method
Volumetric changes assessed in Root Mean Square (RMS)	1 week	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.

Trial Locations

Locations (1)

Blasi Clinica Dental Barcelona; 🇪🇸 Barcelona, Spain