Missing ToothZahnTxNCT04041518
Autotransplantation of Teeth With Intraoperative Extra-corporal Apicoectomy
A study testing Autotransplantation in people with Missing Tooth, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Tooth
- What is being tested?
- Autotransplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jan 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Norbert Jakse, DDS, MD, PhD contact
Austria1 site, 1 recruiting
- Recruiting
Medical University Graz
Graz, Styria, 8010
Petra Rugani, DDS, +4331638580339, petra.rugani@medunigraz.at
Norbert Jakse, PhD, MD, DDS, norbert.jakse@medunigraz.at
About this study
Official title: Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy
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.
Read the 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.
- Conditions
- Missing Tooth
- Being tested
- Autotransplantation
- Keywords
- Autotransplantation, extraoral apicoectomy, revascularization
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutotransplantationProcedure or surgery
Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Autotransplantation and intra-operative extraoral apicoectomy of a permanent tooth. Receives: Procedure: Autotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Healing
Formation of a healthy periodontal ligament with no signs of ankylosis and normal tooth mobility, assessed with electromechanical tapping and intraoral radiography
Measured: 3 to 12 months
Secondary outcomes (2)
Revascularization
Restoration of the circulation of the pulp, assessed with Magnetic resonance imaging and intraoral radiography
Measured: 2 months
Re-innervation
Restoration of Sensitivity of the pulp, assessed with electric pulp testing
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start29 Jan 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Missing ToothStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Rugani, DDS, Principal investigator, Medical University of GrazPetra Rugani, DDS, Study director, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041518
- Sponsor's protocol ID
- 30-519 ex 17/18
- Acronym
- ZahnTx
- Status last verified
- Sep 2021
- First submitted
- 17 Jul 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29935869
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autotransplantation of Teeth With Advanced or Completed Root Development With Intraoperative Extra-corporal Apicoectomy
- ClinicalTrials.gov ID
- NCT04041518
- Acronym / sponsor ID
- ZahnTx / 30-519 ex 17/18
- Conditions
- Missing Tooth
- Keywords
- Autotransplantation, extraoral apicoectomy, revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Procedure: AutotransplantationAutotransplantation and intra-operative extraoral apicoectomy of a permanent tooth. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutotransplantationAutotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy. | Procedure or surgery | Intervention |
Primary outcome
Periodontal Healing
Time frame: 3 to 12 months
Formation of a healthy periodontal ligament with no signs of ankylosis and normal tooth mobility, assessed with electromechanical tapping and intraoral radiography
2 secondary outcomes
Revascularization
Time frame: 2 months
Re-innervation
Time frame: 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 29935869Jakse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Jakse, DDS, MD, PhD contact
Petra Rugani, DDS principal investigator
Medical University of Graz
Petra Rugani, DDS study director
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autotransplantation in people with Missing Tooth, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Rugani, DDS (+4331680339, petra.rugani@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Healing (time frame: 3 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04041518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.