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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2022-04-30

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.

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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).

Conditions

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Occlusal Splints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Analogic-Analogic

Occlusal splints made by conventional impression and conventional fabrication.

Group Type ACTIVE_COMPARATOR

Occlusal Splints Analogic-Analogic

Intervention Type OTHER

Take a conventional impression to the patient and conventional fabrication of the splint.

Analogic-Digital

Occlusal splints made by conventional impression and digital design and fabrication.

Group Type ACTIVE_COMPARATOR

Occlusal Splints Analogic-Digital

Intervention Type OTHER

Take a conventional impression to the patient and digital fabrication of the splint.

Digital-Digital

Occlusal splints performed by intra-oral scanner and digital design and fabrication.

Group Type ACTIVE_COMPARATOR

Occlusal Splints Digital-Digital

Intervention Type OTHER

Take a digital impression to the patient and digital fabrication of the splint.

Interventions

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Occlusal Splints Analogic-Analogic

Take a conventional impression to the patient and conventional fabrication of the splint.

Intervention Type OTHER

Occlusal Splints Analogic-Digital

Take a conventional impression to the patient and digital fabrication of the splint.

Intervention Type OTHER

Occlusal Splints Digital-Digital

Take a digital impression to the patient and digital fabrication of the splint.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes