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

Primary Purpose

Missing Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Autotransplantation
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Tooth focused on measuring Autotransplantation, extraoral apicoectomy, revascularization

Eligibility Criteria

12 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University GrazRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Autotransplantation and intra-operative extraoral apicoectomy of a permanent tooth.

Outcomes

Primary Outcome Measures

Periodontal Healing
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

Revascularization
Restoration of the circulation of the pulp, assessed with Magnetic resonance imaging and intraoral radiography
Re-innervation
Restoration of Sensitivity of the pulp, assessed with electric pulp testing

Full Information

First Posted
July 17, 2019
Last Updated
September 7, 2021
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04041518
Brief Title
Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy
Acronym
ZahnTx
Official Title
Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Tooth
Keywords
Autotransplantation, extraoral apicoectomy, revascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Autotransplantation and intra-operative extraoral apicoectomy of a permanent tooth.
Intervention Type
Procedure
Intervention Name(s)
Autotransplantation
Intervention Description
Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.
Primary Outcome Measure Information:
Title
Periodontal Healing
Description
Formation of a healthy periodontal ligament with no signs of ankylosis and normal tooth mobility, assessed with electromechanical tapping and intraoral radiography
Time Frame
3 to 12 months
Secondary Outcome Measure Information:
Title
Revascularization
Description
Restoration of the circulation of the pulp, assessed with Magnetic resonance imaging and intraoral radiography
Time Frame
2 months
Title
Re-innervation
Description
Restoration of Sensitivity of the pulp, assessed with electric pulp testing
Time Frame
3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra Rugani, DDS
Phone
+4331680339
Email
petra.rugani@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Norbert Jakse, DDS, MD, PhD
Email
norbert.jakse@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Rugani, DDS
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petra Rugani, DDS
Organizational Affiliation
Medical University of Graz
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8010
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Rugani, DDS
Phone
+4331638580339
Email
petra.rugani@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Norbert Jakse, PhD, MD, DDS
Email
norbert.jakse@medunigraz.at

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29935869
Citation
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.
Results Reference
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Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy

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