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Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy

Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04041518
Acronym
ZahnTx
Enrollment
20
Registered
2019-08-01
Start date
2019-01-29
Completion date
2022-08-31
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Missing Tooth

Keywords

Autotransplantation, extraoral apicoectomy, revascularization

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.

Interventions

PROCEDUREAutotransplantation

Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and female consenting and judicious young people and adults * Written consent of the participant and, if applicable, of the legal guardian after education * Planned tooth transplantation with advanced or completed root growth

Exclusion criteria

Contrast agent allergy (Gadovist®) * Contraindications for magnetic resonance imaging (MRI): (pronounced metal restorations, running orthodontics with metal, fixed appliance in the target jaw) * Current or past antiresorptive therapy with bisphosphonates * Further anamnestic general or local risk situation, among others: Anti-angiogenic therapy, History of local radiation therapy, severe coagulation disorder, unadjusted diabetes mellitus, malignant diseases * Acute gingivitis or advanced periodontitis * Participation in an ongoing drug trial (various drugs may distort the result, such as bisphosphonates, cortisone, chemotherapeutics, angiogenesis inhibitors) * heavy smokers (\> 10 per day) * Acute or chronic infections (osteomyelitis) at the surgical site * metabolic diseases (diabetes, hyperparathyroidism, osteomalacia) * Severe kidney dysfunction, severe liver disease * Patients with high-dose corticosteroid therapy * prolonged corticosteroid or radiotherapy in the oral cavity * autoimmune diseases * Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frameDescription
Periodontal Healing3 to 12 monthsFormation of a healthy periodontal ligament with no signs of ankylosis and normal tooth mobility, assessed with electromechanical tapping and intraoral radiography

Secondary

MeasureTime frameDescription
Revascularization2 monthsRestoration of the circulation of the pulp, assessed with Magnetic resonance imaging and intraoral radiography
Re-innervation3, 6, 9 and 12 monthsRestoration of Sensitivity of the pulp, assessed with electric pulp testing

Countries

Austria

Contacts

Primary ContactPetra Rugani, DDS
petra.rugani@medunigraz.at+4331680339
Backup ContactNorbert Jakse, DDS, MD, PhD
norbert.jakse@medunigraz.at

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026