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Clinical Outcome of Dentsply Sirona Profile Implants

Completed
Conditions
Dental Implants
Registration Number
NCT06534034
Lead Sponsor
Aula Dental Avanzada
Brief 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).

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Success Ratethrough study completion, a maximum of 5 years

Number of dental Implants in function with no complications events

Survival Ratethrough study completion, a maximum of 5 years

Number of dental Implants in function with any complications events

Secondary Outcome Measures
NameTimeMethod
Biological complications ratethrough study completion, a maximum of 5 years

Number os dental implant treatment with some biological complication

Mechanical complications ratethrough study completion, a maximum of 5 year

Number of dental implant treatment with some mechanical complication

Trial Locations

Locations (2)

Clínica Dental Esteve

🇪🇸

Alicante, Spain

Clinica Dental Amigó

🇪🇸

Valencia, Spain

Clínica Dental Esteve
🇪🇸Alicante, Spain

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