CClinicalTrials.gg
CompletedNCT06534034Updated Aug 5, 2024

Clinical Outcome of Dentsply Sirona Profile Implants

An observational study in Dental Implants, sponsored by Aula Dental Avanzada. Completed at 2 sites in Spain. Open to participants aged 25 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-05.

Sponsored by Aula Dental Avanzada · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
50
Ages
25 Years to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dental Implants

Keywords

  • Dental Implant
  • Complication
  • Astra Tech Osseospeed Profile
03

In context

Lead sponsor

Aula Dental Avanzada is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All patients who receive Astra Tech Osseospeed Profile dental implant system placement at two private dental clinics in Spain.

Inclusion criteria

  • Patients who have come to private dental clinics with the need to rehabilitate a single edentulous space in the posterior mandibular area.

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with Astra Tech Profile

    Patients who has receive Astra Tech Profile dental implant system placement.

    Procedure: Dental implant placement

Interventions

  • ProcedureDental implant placement

    Dental implant placement on edentulous jaw.

    Also known as: implant surgery, implant prosthesis

06

What researchers measure

Primary outcomes

  1. Success Rate

    Number of dental Implants in function with no complications events

    Time frame: through study completion, a maximum of 5 years

  2. Survival Rate

    Number of dental Implants in function with any complications events

    Time frame: through study completion, a maximum of 5 years

Secondary outcomes

  1. Biological complications rate

    Number os dental implant treatment with some biological complication

    Time frame: through study completion, a maximum of 5 years

  2. Mechanical complications rate

    Number of dental implant treatment with some mechanical complication

    Time frame: through study completion, a maximum of 5 year

07

Study locations

2 sites
  • Clínica Dental Esteve
    Alicante, 03001, Spain
  • Clinica Dental Amigó
    Valencia, 46021, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06534034
Lead sponsor
Aula Dental Avanzada
Responsible party
Guillem Esteve-Pardo (Principal Investigator, Aula Dental Avanzada) — Principal investigator
First posted
Aug 2, 2024
Start date
Jan 1, 2024
Primary completion
Jan 2, 2024
Completion
Jan 3, 2024
Last update
Aug 5, 2024

Study contacts

Guillem Esteve-Pardo, PhD
principal investigator · Aula Dental Avanzada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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