NCT06599320

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

September 5, 2024

Last Update Submit

January 21, 2026

Conditions

Keywords

dental implantcomplications

Outcome Measures

Primary Outcomes (1)

  • Implant survival rate

    percentage of implants in-situ

    25 years

Study Arms (1)

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

Other: Oral rehabilitation with dental implants

Interventions

Patients rehabilitated with implant-supported fixed partial dental prostheses

Partial edentulous patients rehabilitated with at least one dental implant

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • All patients rehabilitated with oral dental implants supporting fixed partial dental prostheses and followed up for at least 20-years.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, Switzerland

Location

Related Publications (1)

  • Buser D, Janner SF, Wittneben JG, Bragger U, Ramseier CA, Salvi GE. 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: a retrospective study in 303 partially edentulous patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):839-51. doi: 10.1111/j.1708-8208.2012.00456.x.

MeSH Terms

Interventions

RehabilitationDental Implants

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesDental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Martin Schimmel

    University of Bern

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
25 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

September 9, 2024

Primary Completion

July 30, 2025

Study Completion

December 31, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations