Clinical Outcome of Dentsply Sirona Profile Implants

NCT ID: NCT06534034

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-01-03

Brief Summary

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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

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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

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Dental Implants

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with Astra Tech Profile

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

Dental implant placement

Intervention Type PROCEDURE

Dental implant placement on edentulous jaw.

Interventions

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Dental implant placement

Dental implant placement on edentulous jaw.

Intervention Type PROCEDURE

Other Intervention Names

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implant surgery implant prosthesis

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aula Dental Avanzada

OTHER

Sponsor Role lead

Responsible Party

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Guillem Esteve-Pardo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillem Esteve-Pardo, PhD

Role: PRINCIPAL_INVESTIGATOR

Aula Dental Avanzada

Locations

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Clínica Dental Esteve

Alicante, , Spain

Site Status

Clinica Dental Amigó

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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RETROPROF

Identifier Type: -

Identifier Source: org_study_id

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