Clinical Outcome of Dentsply Sirona EV Implants

Overview

Retrospective observational study of 500 implants placed between 2014 and 2020 of the same dental implant system (AstraTech Implant System EV, Dentsply Implants, Mölndal, Sweden).

Full Title of Study: “Clinical Outcome of Dentsply Sirona EV Implants: A Retrospective Study of 500 Implants With 6-year Follow-up”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2020

Detailed Description

The purpose of this study is to assess the cumulative survival, success and complications rates obtained with the use of AstraTech Implant System EV in one clinical center from market launch to 2020 All clinical records of patients with this implant system will be collected and the following data will be recorded: Patient gender Date of placement Dimensions and location of implant(s) placed Type of implantation Design of the implant-supported dental prosthesis, single or partial, screw-retained or cemented Date of last radiographic control Type of biological and/or mechanical complications that occurred In biological complications, presence or absence of inflammatory signs and presence or absence of peri-implant bone loss. For mechanical complications, screw loosening, porcelain fracture, fracture of the prosthetic abutment or fracture of the implant. Date of explantation if present The mean, standard deviation (SD), and percentage will be calculated for all recorded parameters. A life table will be made with cumulative survival and success rate (CSR), according to Kaplan-Meier analysis. Correlations and regression analysis will be performed to assess the influence of the variables on the outcomes Conclusions will be drawn based on the results obtained.

Interventions

  • Procedure: Dental implant placement
    • Dental implant placemente on edentulous jaw.

Arms, Groups and Cohorts

  • Patients with Astra Tech EV
    • Patients who has receive Astra Tech dental implant system placement.

Clinical Trial Outcome Measures

Primary Measures

  • Implant Success
    • Time Frame: through study completion, a maximum of 5 year
    • Dental Implants in function with no complications events
  • Implant survival
    • Time Frame: through study completion, a maximum of 5 year
    • Dental Implants in function with any complications events

Secondary Measures

  • Biological complications
    • Time Frame: through study completion, a maximum of 5 year
    • Dental implant treatment with some biological complication
  • Mechanical complications
    • Time Frame: through study completion, a maximum of 5 year
    • Dental implant treatment with some mechanical complication

Participating in This Clinical Trial

Inclusion Criteria

All patients who receive Astra Tech EV dental implant system placement. Exclusion Criteria:

None

Gender Eligibility: All

Male or female

Minimum Age: 18 Years

Maximum Age: 90 Years

Investigator Details

  • Lead Sponsor
    • Aula Dental Avanzada
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guillem Esteve-Pardo, Principal Investigator – Aula Dental Avanzada
  • Overall Official(s)
    • Guillem Esteve-Pardo, DDS, Principal Investigator, Aula Dental Avanzada

References

Norton MR, Åström M. The Influence of Implant Surface on Maintenance of Marginal Bone Levels for Three Premium Implant Brands: A Systematic Review and Meta-analysis. Int J Oral Maxillofac Implants. 2020 Nov/Dec;35(6):1099-1111. doi: 10.11607/jomi.8393.

Astrand P, Engquist B, Dahlgren S, Gröndahl K, Engquist E, Feldmann H. Astra Tech and Brånemark system implants: a 5-year prospective study of marginal bone reactions. Clin Oral Implants Res. 2004 Aug;15(4):413-20.

Derks J, Schaller D, Håkansson J, Wennström JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.

Chae SW, Kim YS, Lee YM, Kim WK, Lee YK, Kim SH. Complication incidence of two implant systems up to six years: a comparison between internal and external connection implants. J Periodontal Implant Sci. 2015 Feb;45(1):23-9. doi: 10.5051/jpis.2015.45.1.23. Epub 2015 Feb 25.

Choi NH, Yoon HI, Kim TH, Park EJ. Improvement in Fatigue Behavior of Dental Implant Fixtures by Changing Internal Connection Design: An In Vitro Pilot Study. Materials (Basel). 2019 Oct 7;12(19). pii: E3264. doi: 10.3390/ma12193264.

Toia M, Galli S, Cecchinato D, Wennerberg A, Jimbo R. Clinical Evidence of OsseoSpeed EV Implants: A Retrospective Study and Characterization of the Newly Introduced System. Int J Periodontics Restorative Dent. 2019 November/December;39(6):863-874. doi: 10.11607/prd.2549. Epub 2017 Aug 23.

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