Dental ImplantsNCT00921583
Long-term Examination of Titanium Dental Implants With a TPS Surface: A Prospective 20-year Case Series Study
An observational study of Dental Implants and Periimplantitis, run by University of Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Implants, Periimplantitis
- What is being tested?
- Long-term examination
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Original group of patient
Who cannot join
- Other patient than from original group
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Dental Implants, Periimplantitis
- Being tested
- Long-term examination
- Keywords
- survival rate, success rate
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term examinationDevice
Follow-up dental implants 20 year in function
| Study group | Role | What they receive |
|---|---|---|
| 1 | Examination of dental implants 20 years in function Receives: Device: Long-term examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
Measured: 20 years after implants installation
Secondary outcomes (1)
Implant success rate
Measured: 20 years after implants installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Buser, Prof, Study director, Dep. Oral surgery and Stomatology, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921583
- Sponsor's protocol ID
- KEK 078/09
- Status last verified
- Apr 2012
- First submitted
- 28 May 2009
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Examination of Titanium Dental Implants With a TPS Surface: A Prospective 20-year Case Series Study
- ClinicalTrials.gov ID
- NCT00921583
- Acronym / sponsor ID
- KEK 078/09
- Conditions
- Dental Implants, Periimplantitis
- Keywords
- survival rate, success rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Long-term examinationExamination of dental implants 20 years in function |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Original group of patient
Key exclusion criteria (1 listed)
- Other patient than from original group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term examinationFollow-up dental implants 20 year in function | Device | 1 |
Primary outcome
Implant survival rate
Time frame: 20 years after implants installation
1 secondary outcome
Implant success rate
Time frame: 20 years after implants installation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Buser, Prof study director
Dep. Oral surgery and Stomatology, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants and Periimplantitis, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival rate (time frame: 20 years after implants installation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2012.