NCT04922489

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

7 years

First QC Date

June 3, 2021

Last Update Submit

June 9, 2021

Conditions

Dental Implants

Keywords

Dental ImplantComplicationAstra Tech EV

Outcome Measures

Primary Outcomes (2)

  • Implant Success

    Dental Implants in function with no complications events

    through study completion, a maximum of 5 year

  • Implant survival

    Dental Implants in function with any complications events

    through study completion, a maximum of 5 year

Secondary Outcomes (2)

  • Biological complications

    through study completion, a maximum of 5 year

  • Mechanical complications

    through study completion, a maximum of 5 year

Study Arms (1)

Patients with Astra Tech EV

Patients who has receive Astra Tech dental implant system placement.

Procedure: Dental implant placement

Interventions

Dental implant placementPROCEDURE

Dental implant placemente on edentulous jaw.

Also known as: Implant surgery, Implant prosthesis
Patients with Astra Tech EV

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale or female
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who receive Astra Tech EV dental implant system placement al private practice in Clinica Dental Esteve in Alicante (Spain).

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Dental Esteve

Alicante, 03001, Spain

Location

Related Publications (6)

  • 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.

    PMID: 33270049BACKGROUND

  • 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.

    PMID: 15248875BACKGROUND

  • 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.

    PMID: 26701919BACKGROUND

  • 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.

    PMID: 25722923BACKGROUND

  • 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.

    PMID: 31591290BACKGROUND

  • 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.

    PMID: 28834532BACKGROUND

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Guillem Esteve-Pardo, DDS

    Aula Dental Avanzada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 10, 2021

Study Start

January 1, 2014

Primary Completion

December 31, 2020

Study Completion

January 1, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)