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
About this trial
This is an interventional diagnostic trial for Endodontic Disease focused on measuring Autotransplantation, Apicoectomy, Revascularisation
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
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
NCT ID
NCT05267249
First Posted
February 23, 2022
Last Updated
February 23, 2022
Sponsor
Medical University of Graz
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