Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy (ZahnTx)
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|ClinicalTrials.gov Identifier: NCT04041518|
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Missing Tooth||Procedure: Autotransplantation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Autotransplantation and intra-operative extraoral apicoectomy of a permanent tooth.
Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.
- Periodontal Healing [ Time Frame: 3 to 12 months ]Formation of a healthy periodontal ligament with no signs of ankylosis and normal tooth mobility, assessed with electromechanical tapping and intraoral radiography
- Revascularization [ Time Frame: 2 months ]Restoration of the circulation of the pulp, assessed with Magnetic resonance imaging and intraoral radiography
- Re-innervation [ Time Frame: 3, 6, 9 and 12 months ]Restoration of Sensitivity of the pulp, assessed with electric pulp testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041518
|Contact: Petra Rugani, DDSfirstname.lastname@example.org|
|Contact: Norbert Jakse, DDS, MD, PhDemail@example.com|
|Principal Investigator:||Petra Rugani, DDS||Medical University of Graz|
|Study Director:||Petra Rugani, DDS||Medical University of Graz|