NCT04041518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

3.4 years

First QC Date

July 17, 2019

Last Update Submit

September 7, 2021

Conditions

Missing Tooth

Keywords

Autotransplantationextraoral apicoectomyrevascularization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Revascularization

    2 months

  • Re-innervation

    3, 6, 9 and 12 months

Study Arms (1)

Intervention

OTHER

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

Procedure: Autotransplantation

Interventions

AutotransplantationPROCEDURE

Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.

Intervention

Eligibility Criteria

Age12 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8010, Austria

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29935869BACKGROUND

MeSH Terms

Conditions

Anodontia

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Petra Rugani, DDS

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

  • Petra Rugani, DDS

    Medical University of Graz

    STUDY DIRECTOR

Central Study Contacts

Petra Rugani, DDS

CONTACT

+4331680339petra.rugani@medunigraz.at

Norbert Jakse, DDS, MD, PhD

CONTACT

norbert.jakse@medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

August 1, 2019

Study Start

January 29, 2019

Primary Completion

June 30, 2022

Study Completion

August 31, 2022

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)