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

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ClinicalTrials.gov Identifier: NCT02464202
Recruitment Status : Unknown
Verified October 2016 by Reinhilde Jacobs, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : June 8, 2015
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Research Foundation Flanders
Information provided by (Responsible Party):
Reinhilde Jacobs, Universitaire Ziekenhuizen Leuven

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Increase Success Rate of Tooth Transplantation Other: stereolithography tooth replica Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

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




Primary Outcome Measures :
  1. success rate [ Time Frame: 5 years ]
  2. survival rate [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464202


Contacts
Contact: Reinhilde Jacobs, MS, PhD +32 16 33 24 52 reinhilde.jacobs@uzleuven.be

Locations
Belgium
KULeuven Recruiting
Leuven, Belgium, 3000
Contact: Reinhilde Jacobs         
Principal Investigator: Reinhilde Jacobs, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Research Foundation Flanders

Responsible Party: Reinhilde Jacobs, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02464202     History of Changes
Other Study ID Numbers: G089213N
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient is already informed and in follow-up after the surgery.

Keywords provided by Reinhilde Jacobs, Universitaire Ziekenhuizen Leuven:
Tooth autotransplantation
stereolithography tooth replica
CBCT
Outcome