Clinical trial NCT04041518: Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy
Official title: Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Missing Tooth
Keywords: Autotransplantation
extraoral apicoectomy
revascularization
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Periodontal Healing
timeFrame: 3 to 12 months
Secondary outcomes:
measure: Revascularization
timeFrame: 2 months
measure: Re-innervation
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Petra Rugani, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: Petra Rugani, DDS
role: STUDY_DIRECTOR
References:
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.