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OpenTrials
Completed

NCT Number: NCT05317182

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.

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Key information

Conditions

Occlusal Splints

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blasi Clinica Dental Barcelona

Barcelona, 08021, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occlusal Splints Analogic-Analogic

Other

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

Occlusal Splints Analogic-Digital

Other

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

Occlusal Splints Digital-Digital

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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