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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

Interventions

  • Other: stereolithography tooth replica
    • Tooth replica will be made and used for preparing the receiving tooth socket during autotransplantation

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • success rate
    • Time Frame: 5 years
  • survival rate
    • Time Frame: 5 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 9 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Collaborator
    • Research Foundation Flanders
  • Provider of Information About this Clinical Study
    • Principal Investigator: Reinhilde Jacobs, Prof. Dr. – Universitaire Ziekenhuizen Leuven
  • Overall Contact(s)
    • Reinhilde Jacobs, MS, PhD, +32 16 33 24 52, reinhilde.jacobs@uzleuven.be

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