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
  Purpose

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.


Condition Intervention
Dental Implants
Periimplantitis
Device: Long-term examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Examination of Titanium Dental Implants With a TPS Surface: A Prospective 20-year Case Series Study

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Implant survival rate [ Time Frame: 20 years after implants installation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Implant success rate [ Time Frame: 20 years after implants installation ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Examination of dental implants 20 years in function
Device: Long-term examination
Follow-up dental implants 20 year in function

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Original group of patient

Exclusion Criteria:

  • Other patient than from original group
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921583

Locations
Switzerland
Chappuis
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Investigators
Study Director: Daniel Buser, Prof Dep. Oral surgery and Stomatology, University of Bern
  More Information

No publications provided

Responsible Party: Chappuis Vivianne, Dep. of Oral Surgery and Stomatology, University of Bern
ClinicalTrials.gov Identifier: NCT00921583     History of Changes
Other Study ID Numbers: KEK 078/09
Study First Received: May 28, 2009
Last Updated: April 12, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
survival rate
success rate

Additional relevant MeSH terms:
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases

ClinicalTrials.gov processed this record on April 16, 2014