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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Missing Tooth
• Intervention / Treatment: Procedure: Autotransplantation

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petra Rugani, DDS; Phone Number: +4331680339; Email: petra.rugani@medunigraz.at
• Study Contact Backup: Name: Norbert Jakse, DDS, MD, PhD; Email: norbert.jakse@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Recruiting
      • Medical University Graz
      • Contact: Petra Rugani, DDS; Phone Number: +4331638580339; Email: petra.rugani@medunigraz.at
      • Contact: Norbert Jakse, PhD, MD, DDS; Email: norbert.jakse@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal Healing	Formation of a healthy periodontal ligament with no signs of ankylosis and normal tooth mobility, assessed with electromechanical tapping and intraoral radiography	3 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revascularization	Restoration of the circulation of the pulp, assessed with Magnetic resonance imaging and intraoral radiography	2 months
Re-innervation	Restoration of Sensitivity of the pulp, assessed with electric pulp testing	3, 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Petra Rugani, DDS, Medical University of Graz; Study Director: Petra Rugani, DDS, Medical University of Graz

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: revascularization; Autotransplantation; extraoral apicoectomy
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: 30-519 ex 17/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No