3D Autotransplantation of Teeth

April 11, 2023 updated by: Hanna Thoren MD, Turku University Hospital
The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hanna Thoren
  • Phone Number: +358 29 450 5000

Study Locations

  • Finland
      • Turku, Finland
        • Recruiting
        • Turku University Hospital
        • Contact:
          • Hanna Thoren
        • Contact:
          • Phone Number: +358 29 450 5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Need for tooth transplantation
  • Open apex tooth available for transplantation

Exclusion Criteria:

  • Facial syndrome
  • Chronic facial pain
  • Allergy to replica material

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year postoperatively
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
One year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Hanna Thorén, MD, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T282/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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