Dental ImplantsNCT06534034
Clinical Outcome of Dentsply Sirona Profile Implants
An observational study of Dental Implants, run by Aula Dental Avanzada at 2 sites in Spain.
Trial summary
This is a retrospective observational study of 50 implants placed between 2013 and 2023 from the same dental implant system (Osseospeed Profile, Dentsply Implants, Mölndal, Sweden). Read more about this study
- Who is it for?
- Ages 25 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2024to 3 Jan 2024
- 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 25 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who receive Astra Tech Osseospeed Profile dental implant system placement at two private dental clinics in Spain.
Who may be able to join
- Patients who have come to private dental clinics with the need to rehabilitate a single edentulous space in the posterior mandibular area.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Clínica Dental Esteve
Alicante, 03001
Clinica Dental Amigó
Valencia, 46021
About this study
Official title: Clinical Outcome of Dentsply Sirona Profile Implants: A 12-year Follow-up Retrospective Study.
This is a retrospective observational study of 50 implants placed between 2013 and 2023 from the same dental implant system (Osseospeed Profile, Dentsply Implants, Mölndal, Sweden).
Read the detailed description
The aim of this study is to evaluate the cumulative survival, success and complication rates obtained with the use of Osseospeed Profile EV implants in two clinical centres with similar characteristics since its launch on the market in 2013, until today.
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 Osseospeed Profile
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 placement on edentulous jaw.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Astra Tech Profile | Patients who has receive Astra Tech Profile 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.
Success Rate
Number of dental Implants in function with no complications events
Measured: through study completion, a maximum of 5 years
Survival Rate
Number of dental Implants in function with any complications events
Measured: through study completion, a maximum of 5 years
Secondary outcomes (2)
Biological complications rate
Number os dental implant treatment with some biological complication
Measured: through study completion, a maximum of 5 years
Mechanical complications rate
Number of 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 posted2 Aug 2024
- Study start1 Jan 2024
- Primary completion2 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 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, PhD, Principal investigator, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534034
- Sponsor's protocol ID
- RETROPROF
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Dentsply Sirona Profile Implants: A 12-year Follow-up Retrospective Study.
- ClinicalTrials.gov ID
- NCT06534034
- Acronym / sponsor ID
- RETROPROF
- Conditions
- Dental Implants
- Keywords
- Dental Implant, Complication, Astra Tech Osseospeed Profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 2 Aug 2024 (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.
This is a retrospective observational study of 50 implants placed between 2013 and 2023 from the same dental implant system (Osseospeed Profile, Dentsply Implants, Mölndal, Sweden).
Detailed description
The aim of this study is to evaluate the cumulative survival, success and complication rates obtained with the use of Osseospeed Profile EV implants in two clinical centres with similar characteristics since its launch on the market in 2013, until today.
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 Profile | – | Procedure: Dental implant placementPatients who has receive Astra Tech Profile dental implant system placement. |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who receive Astra Tech Osseospeed Profile dental implant system placement at two private dental clinics in Spain.
Key inclusion criteria (1 listed)
- Patients who have come to private dental clinics with the need to rehabilitate a single edentulous space in the posterior mandibular area.
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 placement on edentulous jaw. | Procedure or surgery | Patients with Astra Tech Profile |
Primary outcome
Success Rate
Time frame: through study completion, a maximum of 5 years
Number of dental Implants in function with no complications events
Survival Rate
Time frame: through study completion, a maximum of 5 years
Number of dental Implants in function with any complications events
2 secondary outcomes
Biological complications rate
Time frame: through study completion, a maximum of 5 years
Mechanical complications rate
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 5 Aug 2024.
- Individual participant dataSharing planned: No
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Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
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Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
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The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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, PhD principal investigator
Aula Dental Avanzada
2 sites 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 2 sites 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Success Rate (time frame: through study completion, a maximum of 5 years). 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?
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 5 Aug 2024.