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3D Autotransplantation of Teeth

Primary Purpose

Tooth Loss

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

3D generated tooth replica

About this trial

This is an interventional treatment trial for Tooth Loss

Eligibility Criteria

9 Years - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Need for tooth transplantation
Open apex tooth available for transplantation

Exclusion Criteria:

Facial syndrome
Chronic facial pain
Allergy to replica material

Sites / Locations

Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Effect on surgery

Success of transplantation

Arm Description

Duration of surgery, degree of manipulation of the transplant

Normal eruption and root development of the transplant

Outcomes

Primary Outcome Measures

Number of patients with healthy transplanted teeth as assessed by clinical examination at one year.

The transplanted tooth is clinically healthy

Number of patients with healthy transplanted teeth as assessed by radiological examination at one year.

The transplanted tooth is radiologically healthy

Secondary Outcome Measures

Full Information

NCT ID

NCT04120688

First Posted

September 26, 2019

Last Updated

April 11, 2023

Sponsor

Turku University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04120688

Brief Title

3D Autotransplantation of Teeth

Official Title

3D Autotransplantation of Teeth

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 9, 2020 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Effect on surgery

Arm Type

Active Comparator

Arm Description

Duration of surgery, degree of manipulation of the transplant

Arm Title

Success of transplantation

Arm Type

Active Comparator

Arm Description

Normal eruption and root development of the transplant

Intervention Type

Device

Intervention Name(s)

3D generated tooth replica

Intervention Description

3D generated tooth replicas are compared to conventional procedure

Primary Outcome Measure Information:

Title

Number of patients with healthy transplanted teeth as assessed by clinical examination at one year.

Description

The transplanted tooth is clinically healthy

Time Frame

One year postoperatively

Title

Number of patients with healthy transplanted teeth as assessed by radiological examination at one year.

Description

The transplanted tooth is radiologically healthy

Time Frame

One year postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

23 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Need for tooth transplantation Open apex tooth available for transplantation Exclusion Criteria: Facial syndrome Chronic facial pain Allergy to replica material

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hanna Thoren, MD

Phone

+358 29 450 5000

hanna.thoren@utu.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Hanna Thoren

Phone

+358 29 450 5000

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanna Thorén, MD

Organizational Affiliation

University of Turku

Official's Role

Principal Investigator

Facility Information:

Facility Name

Turku University Hospital

City

Turku

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanna Thoren

Phone

+358 29 450 5000

12. IPD Sharing Statement

Plan to Share IPD

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3D Autotransplantation of Teeth

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