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Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy (ZahnTx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04041518
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Missing Tooth Procedure: Autotransplantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Autotransplantation and intra-operative extraoral apicoectomy of a permanent tooth.
Procedure: Autotransplantation
Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Revascularization [ Time Frame: 2 months ]
    Restoration of the circulation of the pulp, assessed with Magnetic resonance imaging and intraoral radiography

  2. Re-innervation [ Time Frame: 3, 6, 9 and 12 months ]
    Restoration of Sensitivity of the pulp, assessed with electric pulp testing

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04041518

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Contact: Petra Rugani, DDS +4331680339
Contact: Norbert Jakse, DDS, MD, PhD

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Medical University Graz Recruiting
Graz, Styria, Austria, 8010
Contact: Petra Rugani, DDS    +4331638580339   
Contact: Norbert Jakse, PhD, MD, DDS   
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Petra Rugani, DDS Medical University of Graz
Study Director: Petra Rugani, DDS Medical University of Graz

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Responsible Party: Medical University of Graz Identifier: NCT04041518    
Other Study ID Numbers: 30-519 ex 17/18
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Graz:
extraoral apicoectomy
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities