- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05842655
Digital Technique to Analyze the Wear of Implants and Natural Tooth as Antagonist.
May 1, 2023 updated by: JAVIER MONTERO, University of Salamanca
Digital Technique to Analyze the Wear of Screw-Retained Implant-Supported Metal-Ceramic Dental Prostheses and Natural Tooth as Antagonist. A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
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Salamanca, Spain, 37008
- University of Salamanca
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
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
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients thats were chosen in order to rehabilitate partial edentulism by dental implants.
|
A novel digital technique to analyze the wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth as antagonist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses
Time Frame: 3 months follow-up appointment
|
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses at 3 months follow-up appointment
|
3 months follow-up appointment
|
|
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses
Time Frame: 6 months follow-up appointment
|
Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses at 6 months follow-up appointment
|
6 months follow-up appointment
|
|
Wear volume (µm3) of the natural tooth as antagonist
Time Frame: 3 months follow-up appointment
|
Wear volume (µm3) of the natural tooth as antagonist at 3 months follow-up appointment
|
3 months follow-up appointment
|
|
Wear volume (µm3) of the natural tooth as antagonist
Time Frame: 6 months follow-up appointment
|
Wear volume (µm3) of the natural tooth as antagonist at 6 months follow-up appointment
|
6 months follow-up appointment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Castellanos-Cosano L, Rodriguez-Perez A, Spinato S, Wainwright M, Machuca-Portillo G, Serrera-Figallo MA, Torres-Lagares D. Descriptive retrospective study analyzing relevant factors related to dental implant failure. Med Oral Patol Oral Cir Bucal. 2019 Nov 1;24(6):e726-e738. doi: 10.4317/medoral.23082.
- Wiley MG. Effects of porcelain on occluding surfaces of restored teeth. J Prosthet Dent. 1989 Feb;61(2):133-7. doi: 10.1016/0022-3913(89)90360-0.
- Hudson JD, Goldstein GR, Georgescu M. Enamel wear caused by three different restorative materials. J Prosthet Dent. 1995 Dec;74(6):647-54. doi: 10.1016/s0022-3913(05)80319-1.
- Fisher RM, Moore BK, Swartz ML, Dykema RW. The effects of enamel wear on the metal-porcelain interface. J Prosthet Dent. 1983 Nov;50(5):627-31. doi: 10.1016/0022-3913(83)90198-1.
- Seghi RR, Rosenstiel SF, Bauer P. Abrasion of human enamel by different dental ceramics in vitro. J Dent Res. 1991 Mar;70(3):221-5. doi: 10.1177/00220345910700031301.
- Oh WS, Delong R, Anusavice KJ. Factors affecting enamel and ceramic wear: a literature review. J Prosthet Dent. 2002 Apr;87(4):451-9. doi: 10.1067/mpr.2002.123851.
- Ohlmann B, Trame JP, Dreyhaupt J, Gabbert O, Koob A, Rammelsberg P. Wear of posterior metal-free polymer crowns after 2 years. J Oral Rehabil. 2008 Oct;35(10):782-8. doi: 10.1111/j.1365-2842.2008.01865.x. Epub 2008 May 9.
- Hmaidouch R, Weigl P. Tooth wear against ceramic crowns in posterior region: a systematic literature review. Int J Oral Sci. 2013 Dec;5(4):183-90. doi: 10.1038/ijos.2013.73. Epub 2013 Oct 18.
- Etman MK, Woolford M, Dunne S. Quantitative measurement of tooth and ceramic wear: in vivo study. Int J Prosthodont. 2008 May-Jun;21(3):245-52. Erratum In: Int J Prosthodont. 2008 Nov-Dec;21(6):508.
- Yilmaz H, Aydin C, Gul BE. Flexural strength and fracture toughness of dental core ceramics. J Prosthet Dent. 2007 Aug;98(2):120-8. doi: 10.1016/S0022-3913(07)60045-6.
- Heintze SD, Zellweger G, Sbicego S, Rousson V, Munoz-Viveros C, Stober T. Wear of two denture teeth materials in vivo-2-year results. Dent Mater. 2013 Sep;29(9):e191-204. doi: 10.1016/j.dental.2013.04.012. Epub 2013 Jun 6.
- Stober T, Geiger A, Rues S, Dreyhaupt J, Rammelsberg P, Ohlmann B. Factors affecting wear of composite resin denture teeth--24-month results from a clinical study. Clin Oral Investig. 2012 Apr;16(2):413-20. doi: 10.1007/s00784-011-0534-y. Epub 2011 Mar 8.
- Zubizarreta-Macho A, Triduo M, Alonso Perez-Barquero J, Guinot Barona C, Albaladejo Martinez A. Novel Digital Technique to Quantify the Area and Volume of Cement Remaining and Enamel Removed after Fixed Multibracket Appliance Therapy Debonding: An In Vitro Study. J Clin Med. 2020 Apr 12;9(4):1098. doi: 10.3390/jcm9041098.
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)
January 1, 2022
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
December 25, 2022
First Submitted That Met QC Criteria
May 1, 2023
First Posted (Estimate)
May 4, 2023
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
May 1, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USAL 2022-AZM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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