Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-01-28 @ 3:36 PM
Study NCT ID:
NCT04041518
Status:
UNKNOWN
Last Update Posted:
2021-09-08
First Post:
2019-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZahnTx
Brief Summary:
Clinical trial to evaluate the success rate of autotransplantation of teeth with advanced or completed root growth with intraoperative extracorporeal root tip resection in 20 patients.
Detailed Description:
Autotransplantation is surgical transposition of a tooth by extraction and replantation into another site in the same patient's mouth. It has become a routine treatment option for missing teeth in the human dentition and a reasonable alternative to dental implants, fixed bridgework, resin-bonded restorations, and removable partial dentures.
Under ideal circumstances, a vital transplanted tooth with healthy periodontal tissues is the final outcome of autotransplantation. Best results for both the rate of revascularization and the further development of the roots are achieved in adolescent teeth with two thirds to three fourths developed roots. According to Andreasen et al., the critical diameter of the apical foramen of the transplanted tooth is 1 mm for successful revascularization. The reported success rates for revascularization of mature teeth with fully developed roots were distinctly lower, and endodontic treatment was considered a standard procedure after transplantations of mature teeth.
Aim of the presented study is to evaluate the success rate of autotransplantation of almost or completely fully developed teeth with intraoperative extracorporeal root tip resection to facilitate revascularization and obviate subsequent root canal treatment.
The primary endpoint is the successful periodontal healing of the graft, the secondary endpoint the revascularization of the graft.
Revascularization is assessed radiologically with intraoral films after four weeks and three, six, nine and twelve months (obliteration of the pulp, no signs of inflammatory root resorption, and magnetic resonance tomography 4 weeks postoperatively.
Patients are followed-up for one year.
Under ideal circumstances, a vital transplanted tooth with healthy periodontal tissues is the final outcome of autotransplantation. Best results for both the rate of revascularization and the further development of the roots are achieved in adolescent teeth with two thirds to three fourths developed roots. According to Andreasen et al., the critical diameter of the apical foramen of the transplanted tooth is 1 mm for successful revascularization. The reported success rates for revascularization of mature teeth with fully developed roots were distinctly lower, and endodontic treatment was considered a standard procedure after transplantations of mature teeth.
Aim of the presented study is to evaluate the success rate of autotransplantation of almost or completely fully developed teeth with intraoperative extracorporeal root tip resection to facilitate revascularization and obviate subsequent root canal treatment.
The primary endpoint is the successful periodontal healing of the graft, the secondary endpoint the revascularization of the graft.
Revascularization is assessed radiologically with intraoral films after four weeks and three, six, nine and twelve months (obliteration of the pulp, no signs of inflammatory root resorption, and magnetic resonance tomography 4 weeks postoperatively.
Patients are followed-up for one year.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: