Clinical Outcome of Dentsply Sirona EV Implants

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922489
• Other study ID #: RETRODSI
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: January 1, 2021

Study information

• Verified date: June 2021
• Source: Aula Dental Avanzada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 1, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Dental Implants

Intervention

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

Locations

Country	Name	City	State
Spain	Clínica Dental Esteve	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Success	Dental Implants in function with no complications events	through study completion, a maximum of 5 year
Primary	Implant survival	Dental Implants in function with any complications events	through study completion, a maximum of 5 year
Secondary	Biological complications	Dental implant treatment with some biological complication	through study completion, a maximum of 5 year
Secondary	Mechanical complications	Dental implant treatment with some mechanical complication	through study completion, a maximum of 5 year