Long-term Examination of Titanium Dental Implants With a TPS Surface: A Prospective 20-year Case Series Study

This study has been completed.
Sponsor:
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00921583
First received: May 28, 2009
Last updated: April 12, 2012
Last verified: April 2012

May 28, 2009
April 12, 2012
June 2009
May 2011   (final data collection date for primary outcome measure)
Implant survival rate [ Time Frame: 20 years after implants installation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00921583 on ClinicalTrials.gov Archive Site
Implant success rate [ Time Frame: 20 years after implants installation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Long-term Examination of Titanium Dental Implants With a TPS Surface: A Prospective 20-year Case Series Study
Long-term Examination of Titanium Dental Implants With a TPS Surface: A Prospective 20-year Case Series Study

Since 1986, newly developed titanium implants with a TPS surface have been utilized for the treatment of partially edentulous patients with implant supported fixed dental prostheses (FTP). In the beginning, these implant types have been sold by Straumann under the brand name "Bonefit implants", later "ITI Dental Implant System" From the beginning, the first 75 patients have been documented in a prospective case series study, and clinical and radiographic results have been reported at 1-year, 3-years, 5-years and 8-years.

The aim of the present study is to examine the long-term outcomes of this original group of patients with at 20 years of clinical function, and to assess the frequency of biological and technical complications during this follow-up period.

Background:

The rehabilitation with implant-supported restorations has been a successful treatment modality in fully and partially edentulous patients since the early 1980s . Today, partially edentulous individuals have become the main group of patients being considered for implant therapy, and several reports have been published showing favorable long-term outcomes with different dental implant systems. In systematic reviews analyzing the long-term performance of osseointegrated implants, clinical studies with 5-year observation periods are frequently included. However, studies with a 10-year observation period are sparse. Only three clinical studies with an observation period of 20-years in edentulous or partially edentulous patients have been found.

Objective:

The objective is to evaluate dental implants after 20 years of function.

Methods:

Partially edentulous patients provided with implants between 1986 and 1989 at the Department of Oral Surgery and Stomatology at the University of Bern recruited for a clinical and radiographic evaluation 20 years after implant installation. A total of 75 patients with 102 implants will be recalled for a clinical and radiographic examination. All implants installed were hollow screw and hollow cylinder implants (Straumann, Waldenburg, Switzerland) with a rough TPS surface. They were placed according to the manufacturer's guidelines. The superstructures consistent in single crowns or fixed partial dentures, which were incorporated 4-6 months postsurgically. All patients will be evaluated using information from patient's charts and from the 20-year examination. Apical radiographs will be taken from the implant and the adjacent tooth. The marginal bone level around the adjacent tooth will also be calculated using the implant shoulder a reference point.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Partially edentulous patients provided with implants between 1986 and 1989 at the Department of Oral Surgery and Stomatology at the University of Bern recruited for a clinical and radiographic evaluation 20 years after implant installation. A total of 75 patients with 102 implants will be recalled for a clinical and radiographic examination. All implants installed were hollow screw and hollow cylinder implants (Straumann, Waldenburg, Switzerland) with a rough TPS surface. They were placed according to the manufacturer's guidelines. The superstructures consistent in single crowns or fixed partial dentures, which were incorporated 4-6 months postsurgically.

  • Dental Implants
  • Periimplantitis
Device: Long-term examination
Follow-up dental implants 20 year in function
1
Examination of dental implants 20 years in function
Intervention: Device: Long-term examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Original group of patient

Exclusion Criteria:

  • Other patient than from original group
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00921583
KEK 078/09
No
Chappuis Vivianne, Dep. of Oral Surgery and Stomatology, University of Bern
University of Bern
Not Provided
Study Director: Daniel Buser, Prof Dep. Oral surgery and Stomatology, University of Bern
University of Bern
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP