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

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ClinicalTrials.gov Identifier: NCT00921583
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : April 13, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Dental Implants Periimplantitis Device: Long-term examination

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.


Study Design

Study Type : Observational
Actual Enrollment : 67 participants
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
Study Start Date : June 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
Examination of dental implants 20 years in function
Device: Long-term examination
Follow-up dental implants 20 year in function


Outcome Measures

Primary Outcome Measures :
  1. Implant survival rate [ Time Frame: 20 years after implants installation ]

Secondary Outcome Measures :
  1. Implant success rate [ Time Frame: 20 years after implants installation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012

Keywords provided by University of Bern:
survival rate
success rate

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