Clinical trial NCT06534034: Clinical Outcome of Dentsply Sirona Profile Implants
Official title: Clinical Outcome of Dentsply Sirona Profile Implants: A 12-year Follow-up Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implants
Keywords: Dental Implant
Complication
Astra Tech Osseospeed Profile
Lead sponsor: Aula Dental Avanzada
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success Rate
timeFrame: through study completion, a maximum of 5 years
measure: Survival Rate
timeFrame: through study completion, a maximum of 5 years
Secondary outcomes:
measure: Biological complications rate
timeFrame: through study completion, a maximum of 5 years
measure: Mechanical complications rate
timeFrame: through study completion, a maximum of 5 year
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Clínica Dental Esteve
city: Valencia
country: Spain
facility: Clinica Dental Amigó
Study officials:
affiliation: Aula Dental Avanzada
name: Guillem Esteve-Pardo, PhD
role: PRINCIPAL_INVESTIGATOR
References: