Tooth LossNCT04120688
3D Autotransplantation of Teeth
A study testing 3D generated tooth replica in people with Tooth Loss, run by Turku University Hospital at 1 site in Finland.
Trial summary
The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults. Read more about this study
- Who is it for?
- Ages 9 to 23 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- 3D generated tooth replica
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 9 Mar 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Need for tooth transplantation
- Open apex tooth available for transplantation
Who cannot join
- Facial syndrome
- Chronic facial pain
- Allergy to replica material
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hanna Thoren contact
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, Turku
Hanna Thoren
+358 29 450 5000
About this study
The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.
- Conditions
- Tooth Loss
- Being tested
- 3D generated tooth replica
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D generated tooth replicaDevice
3D generated tooth replicas are compared to conventional procedure
| Study group | Role | What they receive |
|---|---|---|
| Effect on surgery | Active comparator | Duration of surgery, degree of manipulation of the transplant Receives: Device: 3D generated tooth replica |
| Success of transplantation | Active comparator | Normal eruption and root development of the transplant Receives: Device: 3D generated tooth replica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with healthy transplanted teeth as assessed by clinical examination at one year.
The transplanted tooth is clinically healthy
Measured: One year postoperatively
Number of patients with healthy transplanted teeth as assessed by radiological examination at one year.
The transplanted tooth is radiologically healthy
Measured: One year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start9 Mar 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanna Thoren MD, Turku University Hospital
- Investigators
- Hanna Thorén, MD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120688
- Sponsor's protocol ID
- T282/2019
- Status last verified
- May 2025
- First submitted
- 26 Sep 2019
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Autotransplantation of Teeth
- ClinicalTrials.gov ID
- NCT04120688
- Acronym / sponsor ID
- T282/2019
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Oct 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.
The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect on surgery | Active comparator | Device: 3D generated tooth replicaDuration of surgery, degree of manipulation of the transplant |
| Success of transplantation | Active comparator | Device: 3D generated tooth replicaNormal eruption and root development of the transplant |
Who may qualify
- Ages
- 9 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Need for tooth transplantation
- Open apex tooth available for transplantation
Key exclusion criteria (3 listed)
- Facial syndrome
- Chronic facial pain
- Allergy to replica material
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 |
|---|---|---|
| 3D generated tooth replica3D generated tooth replicas are compared to conventional procedure | Device | Effect on surgery, Success of transplantation |
Primary outcome
Number of patients with healthy transplanted teeth as assessed by clinical examination at one year.
Time frame: One year postoperatively
The transplanted tooth is clinically healthy
Number of patients with healthy transplanted teeth as assessed by radiological examination at one year.
Time frame: One year postoperatively
The transplanted tooth is radiologically healthy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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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.
Hanna Thoren contact
Hanna Thorén, MD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D generated tooth replica in people with Tooth Loss, run by Turku University Hospital at 1 site in Finland.
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 3 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Thoren, MD (+358 29 450 5000, hanna.thoren@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with healthy transplanted teeth as assessed by clinical examination at one year. (time frame: One year postoperatively). 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 14 May 2025.