Skip to main content
OpenTrials
Completed

NCT Number: NCT06534034

Clinical Outcome of Dentsply Sirona Profile Implants

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

25 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Dental Esteve, Alicante, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • None

Treatment and study plan

Dental implant placement

Procedure

Dental implant placement on edentulous jaw.

Other names: implant surgery, implant prosthesis

Primary outcomes

  1. Success Rate

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

    Number of dental Implants in function with no complications events

  2. Survival Rate

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

    Number of dental Implants in function with any complications events

Secondary outcomes

  1. Biological complications rate

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

    Number os dental implant treatment with some biological complication

  2. Mechanical complications rate

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

    Number of dental implant treatment with some mechanical complication

Sponsors and collaborators

Lead sponsor

Aula Dental Avanzada

Other

Registry information

Official study title

Clinical Outcome of Dentsply Sirona Profile Implants: A 12-year Follow-up Retrospective Study.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.