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Digital Technique to Analyze the Wear of Implants and Natural Tooth as Antagonist.

Primary Purpose

Dental Prosthesis Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dental Prosthesis Failure focused on measuring Implant supported, morphometry, screw-retained, digital, wear

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: in good health, who presented partial edentulism in the posterior upper maxilla, were consecutively included to rehabilitate partial edentulism by dental implants Exclusion Criteria: all those who do not meet the inclusion criteria

Sites / Locations

  • University of Salamanca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients thats were chosen in order to rehabilitate partial edentulism by dental implants.

Arm Description

Outcomes

Primary Outcome Measures

Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses at 3 months follow-up appointment
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses at 6 months follow-up appointment
Wear volume (µm3) of the natural tooth as antagonist
Wear volume (µm3) of the natural tooth as antagonist at 3 months follow-up appointment
Wear volume (µm3) of the natural tooth as antagonist
Wear volume (µm3) of the natural tooth as antagonist at 6 months follow-up appointment

Secondary Outcome Measures

Full Information

First Posted
December 25, 2022
Last Updated
May 1, 2023
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05842655
Brief Title
Digital Technique to Analyze the Wear of Implants and Natural Tooth as Antagonist.
Official Title
Digital Technique to Analyze the Wear of Screw-Retained Implant-Supported Metal-Ceramic Dental Prostheses and Natural Tooth as Antagonist. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to describe a novel digital technique to analyze the wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth as antagonist. Materials and methods: Ten patients were consecutively included to rehabilitate partial edentulism by dental implants. Both the screw-retained implant-supported metal-ceramic dental prostheses and the natural tooth as antagonist were submitted to a digital impression through an intraoral scan to generate a Standard Tessellation Language digital file preoperatively (STL1), at 3 months (STL2), and 6 months (STL3) follow-up. Afterwards, an alignment procedure of the digital files (STL1-STL3) was performed on a reverse engineering morphometric software and volume changes at the screw-retained implant-supported metal-ceramic dental prostheses and the natural tooth as antagonist were analyzed using Student's t-test. Moreover, Gage R&R statistical analysis was conducted to analyze the repeatability and reproducibility of the digital technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Prosthesis Failure
Keywords
Implant supported, morphometry, screw-retained, digital, wear

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients thats were chosen in order to rehabilitate partial edentulism by dental implants.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth
Intervention Description
A novel digital technique to analyze the wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth as antagonist
Primary Outcome Measure Information:
Title
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses
Description
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses at 3 months follow-up appointment
Time Frame
3 months follow-up appointment
Title
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses
Description
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses at 6 months follow-up appointment
Time Frame
6 months follow-up appointment
Title
Wear volume (µm3) of the natural tooth as antagonist
Description
Wear volume (µm3) of the natural tooth as antagonist at 3 months follow-up appointment
Time Frame
3 months follow-up appointment
Title
Wear volume (µm3) of the natural tooth as antagonist
Description
Wear volume (µm3) of the natural tooth as antagonist at 6 months follow-up appointment
Time Frame
6 months follow-up appointment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: in good health, who presented partial edentulism in the posterior upper maxilla, were consecutively included to rehabilitate partial edentulism by dental implants Exclusion Criteria: all those who do not meet the inclusion criteria
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Citations:
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Citation
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Digital Technique to Analyze the Wear of Implants and Natural Tooth as Antagonist.

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