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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT02464202

Collaborator

Research Foundation Flanders (Other)

100

Enrollment

Location

Arm

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

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 1, 2013

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

success rate [5 years]
survival rate [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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.

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KULeuven	Leuven		Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven
Research Foundation Flanders

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reinhilde Jacobs, Prof. Dr., Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT02464202

Other Study ID Numbers:

G089213N

First Posted:

Jun 8, 2015

Last Update Posted:

Nov 24, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Reinhilde Jacobs, Prof. Dr., Universitaire Ziekenhuizen Leuven

Tooth autotransplantation

stereolithography tooth replica

CBCT

Outcome

Study Results

No Results Posted as of Nov 24, 2021