search
Back to results

Revascularisation of Autotransplanted Teeth

Primary Purpose

Endodontic Disease, Pulp Canal Obliteration

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

About this trial

This is an interventional diagnostic trial for Endodontic Disease focused on measuring Autotransplantation, Apicoectomy, Revascularisation

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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:

  • 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 of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autotransplantation

Arm Description

Autotransplantation and apicoectomy of mature teeth

Outcomes

Primary Outcome Measures

Survival
Tooth survival

Secondary Outcome Measures

Revascularisation
Occurrence of Revascularisation

Full Information

First Posted
February 23, 2022
Last Updated
February 23, 2022
Sponsor
Medical University of Graz
search

1. Study Identification

Unique Protocol Identification Number
NCT05267249
Brief Title
Revascularisation of Autotransplanted Teeth
Official Title
Revascularisation of Autotransplanted Teeth - Retrospective Analysis of a Novel Technique
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)

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
Retrospective Analysis of a Study cohort that experienced autotransplantation of mature teeth with simultaneous root end resection Note: The study was registered on Clinicaltrials.gov after termination of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Pulp Canal Obliteration
Keywords
Autotransplantation, Apicoectomy, Revascularisation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autotransplantation
Arm Type
Experimental
Arm Description
Autotransplantation and apicoectomy of mature teeth
Intervention Type
Procedure
Intervention Name(s)
Autotransplantation and Apicoectomy
Intervention Description
Autotransplantation of a mature teeth with simultaneous extra-oral root-end resectoin
Primary Outcome Measure Information:
Title
Survival
Description
Tooth survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Revascularisation
Description
Occurrence of Revascularisation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Rugani, DDS
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Available upon reasonable request
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
background

Learn more about this trial

Revascularisation of Autotransplanted Teeth

We'll reach out to this number within 24 hrs