3D Autotransplantation of Teeth
Sponsor
Turku University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04120688
Collaborator
(none)
120
1
2
69.7
1.7
Study Details
Study Description
Brief Summary
The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
3D Autotransplantation of Teeth
Actual Study Start Date
:
Mar 9, 2020
Anticipated Primary Completion Date
:
Dec 31, 2025
Anticipated Study Completion Date
:
Dec 31, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Effect on surgery Duration of surgery, degree of manipulation of the transplant |
Device: 3D generated tooth replica
3D generated tooth replicas are compared to conventional procedure
|
| Active Comparator: Success of transplantation Normal eruption and root development of the transplant |
Device: 3D generated tooth replica
3D generated tooth replicas are compared to conventional procedure
|
Outcome Measures
Primary Outcome Measures
- Number of patients with healthy transplanted teeth as assessed by clinical examination at one year. [One year postoperatively]
The transplanted tooth is clinically healthy
- Number of patients with healthy transplanted teeth as assessed by radiological examination at one year. [One year postoperatively]
The transplanted tooth is radiologically healthy
Eligibility Criteria
Criteria
Ages Eligible for Study:
9 Years
to 23 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Need for tooth transplantation
-
Open apex tooth available for transplantation
Exclusion Criteria:
-
Facial syndrome
-
Chronic facial pain
-
Allergy to replica material
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Turku University Hospital | Turku | Finland |
Sponsors and Collaborators
- Turku University Hospital
Investigators
- Principal Investigator: Hanna Thorén, MD, University of Turku
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hanna Thoren MD,
Professor, Chief Physcian,
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT04120688
Other Study ID Numbers:
- T282/2019
First Posted:
Oct 9, 2019
Last Update Posted:
Apr 2, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: