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Dental Prosthesis FailureNCT05842655

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

A study testing The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth in people with Dental Prosthesis Failure, run by University of Salamanca at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Dental Prosthesis Failure
What is being tested?
The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
1 Jan 2022to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • in good health, who presented partial edentulism in the posterior upper maxilla, were consecutively included to rehabilitate partial edentulism by dental implants

Who cannot join

  • all those who do not meet the inclusion criteria

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Salamanca

    Salamanca, 37008

Other trials in Spain

About this study

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

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.

Being tested
The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth
Keywords
Implant supported, morphometry, screw-retained, digital, wear

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural toothProcedure or surgery

    A novel digital technique to analyze the wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth as antagonist

Study groups in NCT05842655
Study groupRoleWhat they receive
Patients thats were chosen in order to rehabilitate partial edentulism by dental implants.ExperimentalNot described
Receives: Procedure: The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months follow-up appointment

  2. 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

    Measured: 6 months follow-up appointment

  3. Wear volume (µm3) of the natural tooth as antagonist

    Wear volume (µm3) of the natural tooth as antagonist at 3 months follow-up appointment

    Measured: 3 months follow-up appointment

  4. Wear volume (µm3) of the natural tooth as antagonist

    Wear volume (µm3) of the natural tooth as antagonist at 6 months follow-up appointment

    Measured: 6 months follow-up appointment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Jan 2022
  3. Primary completion1 Mar 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05842655
Sponsor's protocol ID
USAL 2022-AZM
Status last verified
May 2023
First submitted
25 Dec 2022
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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.

    PubMed 31655831

  • 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.

    PubMed 2654359

  • 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.

    PubMed 8778391

  • 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.

    PubMed 6358468

  • 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.

    PubMed 1999562

  • 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.

    PubMed 12011863

  • 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.

    PubMed 18482349

  • 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.

    PubMed 24136675

  • 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.

    PubMed 18548965

  • 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.

    PubMed 17692593

  • 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.

    PubMed 23746749

  • 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.

    PubMed 21384126

  • 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.

    PubMed 32290554

Questions about this trial

What is this clinical trial studying?

A study testing The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth in people with Dental Prosthesis Failure, run by University of Salamanca at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wear volume (µm3) of the screw-retained implant-supported metal-ceramic dental prostheses (time frame: 3 months follow-up appointment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05842655, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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