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

NCT ID: NCT02464202

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Increase Success Rate of Tooth Transplantation

Keywords

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Tooth autotransplantation stereolithography tooth replica CBCT Outcome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

stereolithography tooth replica

Intervention Type OTHER

Tooth replica will be made and used for preparing the receiving tooth socket during autotransplantation

Interventions

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stereolithography tooth replica

Tooth replica will be made and used for preparing the receiving tooth socket during autotransplantation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Foundation Flanders

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Reinhilde Jacobs

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KULeuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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EzEldeen M, Wyatt J, Al-Rimawi A, Coucke W, Shaheen E, Lambrichts I, Willems G, Politis C, Jacobs R. Use of CBCT Guidance for Tooth Autotransplantation in Children. J Dent Res. 2019 Apr;98(4):406-413. doi: 10.1177/0022034519828701. Epub 2019 Feb 20.

Reference Type DERIVED
PMID: 30786806 (View on PubMed)

Other Identifiers

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G089213N

Identifier Type: -

Identifier Source: org_study_id