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

Increase Success Rate of Tooth Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464202
• Other study ID #: G089213N
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Increase Success Rate of Tooth Transplantation

Intervention

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

Locations

Country	Name	City	State
Belgium	KULeuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate		5 years
Primary	survival rate		5 years