Jaw, Edentulous, PartiallyNCT04017026
Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
An observational study of Jaw, Edentulous, Partially and Dental Implant Failed, run by University of Bern at 1 site in Switzerland.
Trial summary
In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially, Dental Implant Failed, Implant Complication
- What is being tested?
- Implantation
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 May 2018to 30 Jun 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients treated with a 6mm short implant at the University of Bern were recalled for a clinical and radiographic follow-up examination.
Who may be able to join
- Partially or fully edentulous jaw
- Written informed consent
Who cannot join
- Pregnant women/lactating women
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department for oral surgery of the zmk Bern, University of Bern
Bern, 3010
About this study
In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Clinical and radiographic parameters will be assessed in a follow-up examination.
- Being tested
- Implantation
- Keywords
- Short dental implant, Partially edentulous jaw
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantationDevice
Implantation of 6 mm short implants
| Study group | Role | What they receive |
|---|---|---|
| 6 mm implants | Patients were treated with 6mm short implants (Straumann, SLA, SLActive, 4.1 or 4.8 mm in diameter). Receives: Device: Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rates
Survival rates of short dental implants
Measured: 5-18 years
Secondary outcomes (10)
Radiographic: Annual bone loss
Distance from the implant shoulder to the marginal bone.
Measured: 5-18 years
Clinically: modifying risk factors on implant survival and success
Plaque-index
Measured: 5-18 years
Clinically: modifying risk factors on implant survival and success
Sulcus bleeding index
Measured: 5-18 years
Clinically: modifying risk factors on implant survival and success
Probing depth
Measured: 5-18 years
Clinically: modifying risk factors on implant survival and success
Prosthetic reconstruction
Measured: 5-18 years
Clinically: modifying risk factors on implant survival and success
Implant position
Measured: 5-18 years
Clinically: modifying risk factors on implant survival and success
Crown-to-implant ratio
Measured: 5-18 years
Patient reported outcome measures
Visual analog scale (satisfaction between 0 - 100%)
Measured: 5-18 years
Patient reported outcome measures
Oral health impact profile
Measured: 5-18 years
Implant success rates
Success rates of dental implants. Success rates according to Buser et al. 1990.
Measured: 5-18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start9 May 2018
- Primary completion8 Apr 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivianne Chappuis, DMD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017026
- Sponsor's protocol ID
- 2019_6mm_implants
- Status last verified
- Sep 2020
- First submitted
- 3 Apr 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
- ClinicalTrials.gov ID
- NCT04017026
- Acronym / sponsor ID
- 2019_6mm_implants
- Keywords
- Short dental implant, Partially edentulous jaw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Jul 2019 (actual)
- 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.
In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Clinical and radiographic parameters will be assessed in a follow-up examination.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 mm implants | – | Device: ImplantationPatients were treated with 6mm short implants (Straumann, SLA, SLActive, 4.1 or 4.8 mm in diameter). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with a 6mm short implant at the University of Bern were recalled for a clinical and radiographic follow-up examination.
Key inclusion criteria (2 listed)
- Partially or fully edentulous jaw
- Written informed consent
Key exclusion criteria (1 listed)
- Pregnant women/lactating women
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 |
|---|---|---|
| ImplantationImplantation of 6 mm short implants | Device | 6 mm implants |
Primary outcome
Implant survival rates
Time frame: 5-18 years
Survival rates of short dental implants
10 secondary outcomes
Radiographic: Annual bone loss
Time frame: 5-18 years
Clinically: modifying risk factors on implant survival and success
Time frame: 5-18 years
Clinically: modifying risk factors on implant survival and success
Time frame: 5-18 years
Clinically: modifying risk factors on implant survival and success
Time frame: 5-18 years
Clinically: modifying risk factors on implant survival and success
Time frame: 5-18 years
Clinically: modifying risk factors on implant survival and success
Time frame: 5-18 years
Clinically: modifying risk factors on implant survival and success
Time frame: 5-18 years
Patient reported outcome measures
Time frame: 5-18 years
Patient reported outcome measures
Time frame: 5-18 years
Implant success rates
Time frame: 5-18 years
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 3 Sep 2020.
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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.
Vivianne Chappuis, DMD study chair
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 Jaw, Edentulous, Partially and Dental Implant Failed, 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 2 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 3 Sep 2020. 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 rates (time frame: 5-18 years). 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 3 Sep 2020.