Dental ImplantsNCT04922489
Clinical Outcome of Dentsply Sirona EV Implants
An observational study of Dental Implants, run by Aula Dental Avanzada at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2014to 1 Jan 2021
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: All patients who receive Astra Tech EV dental implant system placement al private practice in Clinica Dental Esteve in Alicante (Spain).
Who may be able to join
- All patients who receive Astra Tech EV dental implant system placement.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Dentsply Sirona EV Implants: A Retrospective Study of 500 Implants With 6-year Follow-up
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).
Read the 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.
- Conditions
- Dental Implants
- Being tested
- Dental implant placement
- Keywords
- Dental Implant, Complication, Astra Tech EV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementProcedure or surgery
Also called Implant surgery, Implant prosthesis
Dental implant placemente on edentulous jaw.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Astra Tech EV | Patients who has receive Astra Tech dental implant system placement. Receives: Procedure: Dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Success
Dental Implants in function with no complications events
Measured: through study completion, a maximum of 5 year
Implant survival
Dental Implants in function with any complications events
Measured: through study completion, a maximum of 5 year
Secondary outcomes (2)
Biological complications
Dental implant treatment with some biological complication
Measured: through study completion, a maximum of 5 year
Mechanical complications
Dental implant treatment with some mechanical complication
Measured: through study completion, a maximum of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jan 2014
- Primary completion31 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
- Investigators
- Guillem Esteve-Pardo, DDS, Principal investigator, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922489
- Sponsor's protocol ID
- RETRODSI
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33270049Astrand 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.
PubMed 15248875Derks 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.
PubMed 26701919Chae 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.
PubMed 25722923Choi 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.
PubMed 31591290Toia 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.
PubMed 28834532
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Dentsply Sirona EV Implants: A Retrospective Study of 500 Implants With 6-year Follow-up
- ClinicalTrials.gov ID
- NCT04922489
- Acronym / sponsor ID
- RETRODSI
- Conditions
- Dental Implants
- Keywords
- Dental Implant, Complication, Astra Tech EV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Astra Tech EV | – | Procedure: Dental implant placementPatients who has receive Astra Tech dental implant system placement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who receive Astra Tech EV dental implant system placement al private practice in Clinica Dental Esteve in Alicante (Spain).
Key inclusion criteria (1 listed)
- All patients who receive Astra Tech EV dental implant system placement.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implant placementAlso: Implant surgery, Implant prosthesisDental implant placemente on edentulous jaw. | Procedure or surgery | Patients with Astra Tech EV |
Primary outcome
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
2 secondary outcomes
Biological complications
Time frame: through study completion, a maximum of 5 year
Mechanical complications
Time frame: through study completion, a maximum of 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Background: PubMed 33270049Norton 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.
- Background: PubMed 15248875Astrand 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.
- Background: PubMed 26701919Derks 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.
- Background: PubMed 25722923Chae 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.
- Background: PubMed 31591290Choi 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.
- Background: PubMed 28834532Toia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillem Esteve-Pardo, DDS principal investigator
Aula Dental Avanzada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Aula Dental Avanzada 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 10 Jun 2021. 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?
Implant Success (time frame: through study completion, a maximum of 5 year). The study lists 2 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 NCT04922489, which also lists 6 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 10 Jun 2021.