Clinical trial NCT04922489: Clinical Outcome of Dentsply Sirona EV Implants
Official title: Clinical Outcome of Dentsply Sirona EV Implants: A Retrospective Study of 500 Implants With 6-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implants
Keywords: Dental Implant
Complication
Astra Tech EV
Lead sponsor: Aula Dental Avanzada
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who receive Astra Tech EV dental implant system placement al private practice in Clinica Dental Esteve in Alicante (Spain).

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

None

Primary outcomes:
measure: Implant Success
timeFrame: through study completion, a maximum of 5 year
measure: Implant survival
timeFrame: through study completion, a maximum of 5 year
Secondary outcomes:
measure: Biological complications
timeFrame: through study completion, a maximum of 5 year
measure: Mechanical complications
timeFrame: through study completion, a maximum of 5 year
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Clínica Dental Esteve
Study officials:
affiliation: Aula Dental Avanzada
name: Guillem Esteve-Pardo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norton MR, Astrom 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.
citation: Astrand P, Engquist B, Dahlgren S, Grondahl K, Engquist E, Feldmann H. Astra Tech and Branemark system implants: a 5-year prospective study of marginal bone reactions. Clin Oral Implants Res. 2004 Aug;15(4):413-20. doi: 10.1111/j.1600-0501.2004.01028.x.
citation: Derks J, Schaller D, Hakansson J, Wennstrom 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.
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.
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):3264. doi: 10.3390/ma12193264.
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.