An interventional study of stereolithography tooth replica in Increase Success Rate of Tooth Transplantation, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 9 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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 (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:
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
success rate
Time frame: 5 years
survival rate
Time frame: 5 years
Plan to share: No — Patient is already informed and in follow-up after the surgery.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven