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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.
 
ClinicalTrials.gov Identifier: NCT04041518
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE August 1, 2019
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE January 29, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy
Official Title  ICMJE Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Missing Tooth
Intervention  ICMJE Procedure: Autotransplantation
Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.
Study Arms  ICMJE Intervention
Autotransplantation and intra-operative extraoral apicoectomy of a permanent tooth.
Intervention: Procedure: Autotransplantation
Publications * Jakse N, Ruckenstuhl M, Rugani P, Kirnbauer B, Sokolowski A, Ebeleseder K. Influence of Extraoral Apicoectomy on Revascularization of an Autotransplanted Tooth: A Case Report. J Endod. 2018 Aug;44(8):1298-1302. doi: 10.1016/j.joen.2018.04.016. Epub 2018 Jun 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Petra Rugani, DDS +4331680339 petra.rugani@medunigraz.at
Contact: Norbert Jakse, DDS, MD, PhD norbert.jakse@medunigraz.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04041518
Other Study ID Numbers  ICMJE 30-519 ex 17/18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petra Rugani, DDS Medical University of Graz
Study Director: Petra Rugani, DDS Medical University of Graz
PRS Account Medical University of Graz
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP