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

Sponsor

Universitat Internacional de Catalunya (Other)

Overall Status

Completed

CT.gov ID

NCT05317182

Collaborator

(none)

Enrollment

Location

Arms

2.4

Actual Duration (Months)

16.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Occlusal Splints	Other: Occlusal Splints Analogic-Analogic Other: Occlusal Splints Analogic-Digital Other: Occlusal Splints Digital-Digital	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 17, 2022

Actual Primary Completion Date :

Apr 15, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Analogic-Analogic

Occlusal splints made by conventional impression and conventional fabrication.

Other: Occlusal Splints Analogic-Analogic

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

Active Comparator: Analogic-Digital

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

Other: Occlusal Splints Analogic-Digital

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

Active Comparator: Digital-Digital

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

Other: Occlusal Splints Digital-Digital

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blasi Clinica Dental Barcelona	Barcelona		Spain	08021

Sponsors and Collaborators

Universitat Internacional de Catalunya

Investigators

Study Director: Miguel Roig, DDS, PhD, Universitat Internacional de Catalunya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alvaro Blasi, Principal investigator, Universitat Internacional de Catalunya

ClinicalTrials.gov Identifier:

NCT05317182

Other Study ID Numbers:

REST-ECL-2021-07

First Posted:

Apr 7, 2022

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alvaro Blasi, Principal investigator, Universitat Internacional de Catalunya

Digital Dentistry

Occlusal records

Intraoral scan

Additional relevant MeSH terms:

Salicylic Acid

Study Results

No Results Posted as of May 18, 2022