Use of CBCT-based Tooth Replica in Tooth Autotransplantation to Improve the Outcome of Tooth Replacement in Children

November 15, 2021 updated by: Reinhilde Jacobs, Universitaire Ziekenhuizen KU Leuven

Use of Stereolithographic Model in Tooth Autotransplantation and Periodontal Ligament Stem Cells for Pulp Revascularization and Reinnervation to Increase the Success Rate for Tooth Replacement in Children

The aim of this study lies in comparing the outcome of the proposed technique in a large sample size group to the outcome of the conventional tooth autotransplantation method and to provide sufficient evidence for improving the long-term success rate of the tooth autotransplantation procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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 Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KULeuven

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 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

The subjects will be divided in two groups according to different surgical protocols.

  1. Pediatric subjects (age between 9-18 years) treated with the CBCT-based replica procedure (prospective approach).

    Pediatric subjects (N=50) that missed their teeth due to agenesis or lost their permanent teeth due to trauma, caries, and endodontic failure and referred to dentistry department for replacement of the missing tooth by means of tooth autotransplantation.

  2. Pediatric subjects (age between 9-18 years) treated with the conventional method (prospective and retrospective).

Pediatric subjects (N=50) that missed their teeth due to agenesis or lost their permanent teeth due to trauma, caries, and endodontic failure and referred to dentistry department for replacement of the missing tooth by means of tooth autotransplantation.

A matched control patient will be selected with the focus on a very similar surgical challenge, based on age, gender and a matching donor tooth with the same stage of root development and host bed.

Exclusion Criteria:

  • Potential participants (case and control) will be excluded if follow-up data are missing for the one-year follow-up.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stereolithography tooth replica
stereolithographic tooth replica used as a guide for tooth autotransplantation decreases extra-alveolar time and reduces trauma to periodontal ligament tissue therefore increasing the success rate after transplantation
Other: stereolithography tooth replica
Tooth replica will be made and used for preparing the receiving tooth socket during autotransplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival rate
Time Frame: 5 years
5 years
success rate
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Research Foundation Flanders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • G089213N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient is already informed and in follow-up after the surgery.

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.

Clinical Trials on Increase Success Rate of Tooth Transplantation

Clinical Trials on stereolithography tooth replica

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe