Viewing Study NCT06599320



Ignite Creation Date: 2024-10-25 @ 7:51 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06599320
Status: ENROLLING_BY_INVITATION
Last Update Posted: None
First Post: 2024-09-05

Brief Title: Variables for Long-term Success in Implant Dentistry
Sponsor: None
Organization: None

Study Overview

Official Title: Variables for Long-term Success in Implant Dentistry a Retrospective Cross-sectional Study with a 25 Year Follow-up or More
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aims of the present retrospective 10-year study of a sample of 459 patients with 753 sandblasted and acid-etched SLA titanium oral implants are

to assess the clinical parameters at SLA implants after 10 years in function
to assess the crestal bone levels at SLA implants after 10 years in function
to assess and compare the microbiological conditions at SLA implants and their adjacent teeth after 10 years of function
to assess the periodontal conditions in patients having received SLA implants 10 years ago
to establish a baseline data set for future prospective studies on patients having received SLA implants 10 years ago
to assess the incidence rates of biological technical traumatic failures complications with SLA implants
to assess the incidence rates of technical failures complications with prosthetic components on SLA implants
to assess the incidence rates of biological technical mechanical esthetic failures complications with prosthetic reconstructions on SLA implants
to find potential risk factors for biological failures complications with SLA implants ie patients having lost their teeth due to different reasons eg partial anodontia caries periodontitis endodontic failure trauma vertical root fracture ii to calculate the success rates using different thresholds set as success criteria iii to evaluate the influence of medical conditions and tobacco smoking on the long-term prognosis of titanium oral implants and iv to assess the frequency and quality of maintenance
to find potential risk factors for mechanical technical esthetic failurescomplications with reconstructions seated on SLA implants
to assess the treatment need and utility of implant therapy after 10 years in patients having received SLA implants
Detailed Description: Specific aims

The aims of the present retrospective 10-year study of a sample of 459 patients with 753 sandblasted and acid-etched SLA titanium oral implants are

to assess the clinical parameters at SLA implants after 10 years in function
to assess the crestal bone levels at SLA implants after 10 years in function
to assess and compare the microbiological conditions at SLA implants and their adjacent teeth after 10 years of function
to assess the periodontal conditions in patients having received SLA implants 10 years ago
to establish a baseline data set for future prospective studies on patients having received SLA implants 10 years ago
to assess the incidence rates of biological technical traumatic failures complications with SLA implants
to assess the incidence rates of technical failures complications with prosthetic components on SLA implants
to assess the incidence rates of biological technical mechanical esthetic failures complications with prosthetic reconstructions on SLA implants
to find potential risk factors for biological failures complications with SLA implants ie patients having lost their teeth due to different reasons eg partial anodontia caries periodontitis endodontic failure trauma vertical root fracture ii to calculate the success rates using different thresholds set as success criteria iii to evaluate the influence of medical conditions and tobacco smoking on the long-term prognosis of titanium oral implants and iv to assess the frequency and quality of maintenance
to find potential risk factors for mechanical technical esthetic failurescomplications with reconstructions seated on SLA implants
to assess the treatment need and utility of implant therapy after 10 years in patients having received SLA implants

Material and methods Out of the pool of patients from the Departments of Oral Surgery and Periodontology and Fixed Prosthodontics at the University of Bern Switzerland all patients having received at least one dental implant will be recruited for a comprehensive evaluation 10 years after implant installation and delivery of the reconstruction The patients had been treated according to a comprehensive treatment strategy prior to the installation of implants and incorporation of reconstructions All patients were offered maintenance care that was provided either in the School of Dental Medicine University of Bern Switzerland or in the dental practices of the referring dentists at intervals between 3 and 6 months

All the implants installed were solid screws SS with a diameter of 33 41 or 48 mm a length between 6-14 mm and a sandblasted and acid-etched surface SLA Straumann Dental Implant System Institute Straumann AG Basel Switzerland The implants were placed according to the manufacturers instructions The reconstructions were either cemented or screw-retained and consisted of single-unit crowns SCs or short-span fixed dental prostheses FDPs with or without cantilever extensions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None