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

May 16, 2022 updated by: Alvaro Blasi, Universitat Internacional de Catalunya

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08021
        • BLASI Clínica Dental Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric changes assessed in Root Mean Square (RMS)
Time Frame: 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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REST-ECL-2021-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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