- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06599320
Variables for Long-term Success in Implant Dentistry
Variables for Long-term Success in Implant Dentistry: A Retrospective Cross-sectional Study With a 25 Year Follow-up or More
The aims of the present retrospective 25-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 25 years in function
- to assess the crestal bone levels at SLA implants after 25 years in function
- to assess and compare the microbiological conditions at SLA implants and their adjacent teeth after 25 years of function
- to assess the periodontal conditions in patients having received SLA implants 25 years ago
- to establish a baseline data set for future prospective studies on patients having received SLA implants 25 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; i.e. patients having lost their teeth due to different reasons (e.g. 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 failures/complications with reconstructions seated on SLA implants
- to assess the treatment need and utility of implant therapy after 25 years in patients having received SLA implants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific aims
The aims of the present retrospective 25-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 25 years in function
- to assess the crestal bone levels at SLA implants after 25 years in function
- to assess and compare the microbiological conditions at SLA implants and their adjacent teeth after 25 years of function
- to assess the periodontal conditions in patients having received SLA implants 25 years ago
- to establish a baseline data set for future prospective studies on patients having received SLA implants 25 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; i.e. patients having lost their teeth due to different reasons (e.g. 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 failures/complications with reconstructions seated on SLA implants
- to assess the treatment need and utility of implant therapy after 25 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 25 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 3.3, 4.1 or 4.8 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 manufacturer's 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 extension(s).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland
- University of Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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 25 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 3.3, 4.1 or 4.8 mm, a length between 6-14 mm and a sandblasted and acid-etched surface (SLA) (Straumann® Dental Implant System, Institute Straumann AG, Basel, Switzerland).
Description
Inclusion Criteria:
All patients rehabilitated with oral dental implants supporting fixed partial dental prostheses and followed up for at least 20-years.
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Partial edentulous patients rehabilitated with at least one dental implant
Partial edentulous patients rehabilitated with at least one dental implant in function for at least 20-years
|
Patients rehabilitated with implant-supported fixed partial dental prostheses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant survival rate
Time Frame: 25 years
|
percentage of implants in-situ
|
25 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Martin Schimmel, University of Bern
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Therapeutics
- Equipment and Supplies
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Aftercare
- Continuity of Patient Care
- Biomedical and Dental Materials
- Manufactured Materials
- Technology, Industry, and Agriculture
- Prostheses and Implants
- Dentistry
- Dental Materials
- Dental Prosthesis
- Prosthodontics
- Rehabilitation
- Dental Implants
Other Study ID Numbers
- 2023-02279
- ITI n 1574_2021 (Other Grant/Funding Number: International Team for Implantology)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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