Clinical Outcome of Dentsply Sirona Profile Implants

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).

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: Dental implant placement

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Astra Tech Profile; Patients who has receive Astra Tech Profile dental implant system placement.	Procedure: Dental implant placement; Dental implant placement on edentulous jaw.; Other Names: implant surgery; implant prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	Number of dental Implants in function with no complications events	through study completion, a maximum of 5 years
Survival Rate	Number of dental Implants in function with any complications events	through study completion, a maximum of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological complications rate	Number os dental implant treatment with some biological complication	through study completion, a maximum of 5 years
Mechanical complications rate	Number of dental implant treatment with some mechanical complication	through study completion, a maximum of 5 year

Collaborators and Investigators

• Sponsor: Aula Dental Avanzada
• Investigators: Principal Investigator: Guillem Esteve-Pardo, PhD, Aula Dental Avanzada

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 2, 2024
• Study Completion (Actual): January 3, 2024

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Dental Implant; Complication; Astra Tech Osseospeed Profile
• Other Study ID Numbers: RETROPROF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No