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

NCT05317182 | Completed

• 1 other identifier: REST-ECL-2021-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Occlusal Splints

Keywords

Digital Dentistry; Occlusal records; Intraoral scan

Outcome Measures

Primary Outcomes (1)

• Volumetric changes assessed in Root Mean Square (RMS)

  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

Study Arms (3)

Analogic-Analogic

ACTIVE COMPARATOR

Occlusal splints made by conventional impression and conventional fabrication.

Other: Occlusal Splints Analogic-Analogic

Analogic-Digital

ACTIVE COMPARATOR

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

Other: Occlusal Splints Analogic-Digital

Digital-Digital

ACTIVE COMPARATOR

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

Other: Occlusal Splints Digital-Digital

Interventions

Occlusal Splints Analogic-Analogic OTHER

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

Analogic-Analogic

Occlusal Splints Analogic-Digital OTHER

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

Analogic-Digital

Occlusal Splints Digital-Digital OTHER

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

Digital-Digital

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 to 70 years old.
• Patients who maintain until first molar in both arches.
• Patients who need occlusal splints due to bruxism.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Blasi Clinica Dental Barcelona

Barcelona, 08021, Spain

Location

Related Publications (1)

• Blasi A, Henarejos-Domingo V, Palacios-Banuelos R, Aparicio C, Roig M. Comparison accuracy of digital and analog method using milled occlusal splints. J Esthet Restor Dent. 2023 Oct;35(7):1103-1112. doi: 10.1111/jerd.13039. Epub 2023 Mar 21.

  PMID: 36942721 DERIVED

Study Officials

• Miguel Roig, DDS, PhD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: April 7, 2022
• Study Start: February 17, 2022
• Primary Completion: April 15, 2022
• Study Completion: April 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)