EdentulismNCT06623968
A 39-year Follow-up Study on the World´s First Single Dental Implants
An observational study of Edentulism, run by Branemarkkliniken.
Trial summary
This is a comprehensive, long-term follow-up study of single-implant treatments. At the Brånemark Clinic in Gothenburg, Sweden, during the period of 1982-1985, 16 patients received single-tooth implants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulism
- What is being tested?
- Dental implants
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 1982to 30 Jun 2024
- How long will I take part?
- 39 Years
- 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: All living patient included in the original prospective study
Who may be able to join
- Patient with diagnosis singel-tooth gap Patient with singel-tooth implants
Who cannot join
- patient with bridge constructions
About this study
This is a comprehensive, long-term follow-up study of single-implant treatments. At the Brånemark Clinic in Gothenburg, Sweden, during the period of 1982-1985, 16 patients received single-tooth implants. This study evaluates the survival rate of the implants after nearly four decades, focusing on the biological and technical complications.
Of the original 16 patients with a total of 23 implants, 14 patients with 19 implants were available for the follow-up and were included in the study. Clinical and radiographic examinations were performed on these patients.
- Conditions
- Edentulism
- Being tested
- Dental implants
- Keywords
- dental implants, edentulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantsProcedure or surgery
Long-term follow-up study on singel-tooth implants
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological and technical complications
Long-term follow-up of singel-tooth implants with regard to biological and/or technical complications
Measured: From enrollment in 1982 - today
Marginal bone level
Marginal bone level changes in mm
Measured: from 1982 to today
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Dec 1982
- Primary completion31 Dec 1985
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 23 participants (actual)
- Target duration
- 39 Years
Sponsor and investigators
- Lead sponsor
- Branemarkkliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623968
- Sponsor's protocol ID
- EPN 2023-00888-01
- Status last verified
- Oct 2024
- First submitted
- 24 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 39-year Follow-up Study on the World´s First Single Dental Implants
- ClinicalTrials.gov ID
- NCT06623968
- Acronym / sponsor ID
- EPN 2023-00888-01
- Conditions
- Edentulism
- Keywords
- dental implants, edentulism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BranemarkklinikenUniversity, hospital or other
- Study start
- 1 Dec 1982 (actual)
- Primary completion
- 31 Dec 1985 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 Oct 2024 (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.
This is a comprehensive, long-term follow-up study of single-implant treatments. At the Brånemark Clinic in Gothenburg, Sweden, during the period of 1982-1985, 16 patients received single-tooth implants. This study evaluates the survival rate of the implants after nearly four decades, focusing on the biological and technical complications.
Of the original 16 patients with a total of 23 implants, 14 patients with 19 implants were available for the follow-up and were included in the study. Clinical and radiographic examinations were performed on these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 39 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All living patient included in the original prospective study
Key inclusion criteria (1 listed)
- Patient with diagnosis singel-tooth gap Patient with singel-tooth implants
Key exclusion criteria (1 listed)
- patient with bridge constructions
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 |
|---|---|---|
| Dental implantsLong-term follow-up study on singel-tooth implants | Procedure or surgery | – |
Primary outcome
Biological and technical complications
Time frame: From enrollment in 1982 - today
Long-term follow-up of singel-tooth implants with regard to biological and/or technical complications
Marginal bone level
Time frame: from 1982 to today
Marginal bone level changes in mm
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 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Edentulism
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Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
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Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
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Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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Active, not recruiting
Single-implant Versus Two-implant Mandibular Overdentures
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulism, run by Branemarkkliniken.
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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Biological and technical complications (time frame: From enrollment in 1982 - today). The study lists 2 primary outcomes in all. 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 Oct 2024.