NCT04120688

Brief Summary

The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

5.8 years

First QC Date

September 26, 2019

Last Update Submit

May 9, 2025

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (2)

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

    The transplanted tooth is clinically healthy

    One year postoperatively

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

    The transplanted tooth is radiologically healthy

    One year postoperatively

Study Arms (2)

Effect on surgery

ACTIVE COMPARATOR

Duration of surgery, degree of manipulation of the transplant

Device: 3D generated tooth replica

Success of transplantation

ACTIVE COMPARATOR

Normal eruption and root development of the transplant

Device: 3D generated tooth replica

Interventions

3D generated tooth replicaDEVICE

3D generated tooth replicas are compared to conventional procedure

Effect on surgerySuccess of transplantation

Eligibility Criteria

Age9 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Turku, Finland

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Hanna Thorén, MD

    University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Thoren, MD

CONTACT

+358 29 450 5000hanna.thoren@utu.fi

Hanna Thoren

CONTACT

+358 29 450 5000

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Physcian

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 9, 2019

Study Start

March 9, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)