Tooth LossOpenApexTNCT07393997
Autogenous Tooth Transplantation With Instrumentally Simulated Open Apex and Platelet-Rich Fibrin
A study testing Autogenous Tooth Transplantation and Alveolar Prf graft in people with Tooth Loss and Tooth Diseases, run by University of Bari Aldo Moro at 1 site in Italy.
Trial summary
Autogenous tooth transplantation (autotransplantation) represents a biologically valid alternative to implant therapy, particularly in young patients where implant placement is contraindicated due to ongoing skeletal growth. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Tooth Diseases, Reimplant; Complications
- What is being tested?
- Autogenous Tooth Transplantation and Alveolar Prf graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Autotransplantation will be performed in selected cases with favorable biological and functional prognosis, including:
- Early loss of permanent teeth due to trauma, extensive caries, or agenesis.
- Dental agenesis, particularly involving premolars or incisors, when a suitable donor tooth is available.
- Replacement of non-restorable teeth (fractures or destructive caries).
- Preservation of alveolar bone in growing patients where implant therapy is contraindicated.
- Functional and aesthetic rehabilitation of anterior teeth in pediatric and adolescent patients.
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- Post-traumatic oral rehabilitation in young patients.
- Good general and oral health.
- Presence of a vital and intact periodontal ligament on the donor tooth.
- Adequate recipient site dimensions and morphology, or surgically adaptable.
- Absence of active infection at the recipient site. Donor Tooth Selection Criteria
- Tooth extracted for orthodontic purposes.
- Impacted or erupting third molars with compatible morphology.
- Suitable supernumerary teeth.
Who cannot join
- Poor patient compliance.
- Active infection at the recipient site.
- Smoking of more than 15 cigarettes a day
- •. Untreated periodontal disease
- Pregnancy or breastfeeding at date of inclusion
- Acute infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nicola De Giglio, Dr. contact
Italy1 site, 1 recruiting
- Recruiting
University of Bari Aldo Moro, Hospital
Bari, 70124
Giuseppe D'Albis, Dr.
Nicola De Giglio, Dr., giuseppe.dalbis@uniba.it
About this study
Official title: Clinical Evaluation of Autogenous Tooth Transplantation With Instrumentally Simulated Open Apex and Autologous Platelet-Rich Fibrin (PRF) Support in Teeth With Complete Root Formation
Autogenous tooth transplantation (autotransplantation) represents a biologically valid alternative to implant therapy, particularly in young patients where implant placement is contraindicated due to ongoing skeletal growth. This approach preserves alveolar bone volume, maintains periodontal proprioception, and allows physiological adaptation over time.
Read the detailed description
One of the main limitations of autotransplantation in teeth with complete root formation is the absence of pulpal revascularization following apical closure, which frequently leads to pulp necrosis and the subsequent need for endodontic treatment. Root canal therapy may compromise the structural integrity of the tooth and negatively affect long-term outcomes.
The combined use of simulated apical patency and autologous PRF is expected to enhance pulpal revascularization, reduce the incidence of pulp necrosis, and improve the biological and clinical outcomes of autogenous tooth transplantation in teeth with complete root formation.
This protocol aims to expand the indications for autogenous tooth transplantation by introducing a biologically driven approach that combines surgical and regenerative techniques. The use of autologous PRF may represent a valuable adjunct in improving healing and long-term success in challenging clinical scenarios.
- Conditions
- Tooth Loss, Tooth Diseases, Reimplant; Complications
- Being tested
- Autogenous Tooth Transplantation, Alveolar Prf graft
- Medical subject headings
- Tooth Loss, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous Tooth TransplantationProcedure or surgery
After atraumatic extraction of the donor tooth, a simulated apical opening will be created using rotary instruments to induce apical patency and replicate the biological conditions of an open apex, potentially favoring pulpal revascularization.
Alveolar Prf graftProcedure or surgery
To enhance clot formation and promote angiogenesis and tissue regeneration, autologous platelet-rich fibrin (PRF) will be used in the recipient site.
PRF Collection and Preparation
- Prior to surgery, peripheral venous blood will be collected from the patient using sterile tubes without anticoagulants.
- The blood samples will be immediately processed using a standardized centrifugation protocol, allowing the separation of a fibrin matrix enriched with platelets and leukocytes.
- After centrifugation, the PRF clot will be gently removed and prepared under sterile conditions for clinical use.
PRF Placement
- The autologous PRF will be placed directly into the recipient alveolus before positioning the donor tooth.
- The PRF matrix will act as a biological scaffold, promoting clot stabilization, neovascularization, and early healing of the periodontal and pulpal tissues.
| Study group | Role | What they receive |
|---|---|---|
| Tooth loss | Experimental | Patients presenting with hopeless teeth Receives: Procedure: Autogenous Tooth Transplantation; Procedure: Alveolar Prf graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resporption
Rx to evalue internal or external root resorption. Present or Not.
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Vitality
Pulp vitality will be assessed during follow-up using standardized sensibility tests. ( electric test). Vitality : Yes or None
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Mobility
Mobility Test. Grade I, Grade II or Grade III
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
Inflammation
signs of inflammation will be monitored. Blood on Probing: Yes or None
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
periodontal health
Periodontal Chart (mm). 6 point for each tooth.
Measured: 1 month, 3 months, 6 months, 1 year, 2 years
bone remodeling
Assess periodontal integration and bone remodeling by Rx. Comparing Rx.
Measured: 1 month, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jan 2026
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, University of Bari Aldo Moro
- Investigators
- Giuseppe D'Albis, Dr., Principal investigator, University of Bari Aldo MoroNicola De Giglio, Dr., Principal investigator, University of Bari Aldo MoroSaverio Capodiferro, Prof. Dr., Study director, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393997
- Sponsor's protocol ID
- OpenApexTechnique
- Acronym
- OpenApexT
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Autogenous Tooth Transplantation With Instrumentally Simulated Open Apex and Autologous Platelet-Rich Fibrin (PRF) Support in Teeth With Complete Root Formation
- ClinicalTrials.gov ID
- NCT07393997
- Acronym / sponsor ID
- OpenApexT / OpenApexTechnique
- Conditions
- Tooth Loss, Tooth Diseases, Reimplant; Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
Autogenous tooth transplantation (autotransplantation) represents a biologically valid alternative to implant therapy, particularly in young patients where implant placement is contraindicated due to ongoing skeletal growth. This approach preserves alveolar bone volume, maintains periodontal proprioception, and allows physiological adaptation over time.
Detailed description
One of the main limitations of autotransplantation in teeth with complete root formation is the absence of pulpal revascularization following apical closure, which frequently leads to pulp necrosis and the subsequent need for endodontic treatment. Root canal therapy may compromise the structural integrity of the tooth and negatively affect long-term outcomes.
The combined use of simulated apical patency and autologous PRF is expected to enhance pulpal revascularization, reduce the incidence of pulp necrosis, and improve the biological and clinical outcomes of autogenous tooth transplantation in teeth with complete root formation.
This protocol aims to expand the indications for autogenous tooth transplantation by introducing a biologically driven approach that combines surgical and regenerative techniques. The use of autologous PRF may represent a valuable adjunct in improving healing and long-term success in challenging clinical scenarios.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth loss | Experimental | Procedure: Autogenous Tooth Transplantation, Procedure: Alveolar Prf graftPatients presenting with hopeless teeth |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Autotransplantation will be performed in selected cases with favorable biological and functional prognosis, including:
- Early loss of permanent teeth due to trauma, extensive caries, or agenesis.
- Dental agenesis, particularly involving premolars or incisors, when a suitable donor tooth is available.
- Replacement of non-restorable teeth (fractures or destructive caries).
- Preservation of alveolar bone in growing patients where implant therapy is contraindicated.
Key exclusion criteria (6 listed)
- Poor patient compliance.
- Active infection at the recipient site.
- Smoking of more than 15 cigarettes a day
- •. Untreated periodontal disease
- Pregnancy or breastfeeding at date of inclusion
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 |
|---|---|---|
| Autogenous Tooth TransplantationAfter atraumatic extraction of the donor tooth, a simulated apical opening will be created using rotary instruments to induce apical patency and replicate the biological conditions of an open apex, potentially favoring pulpal revascularization. | Procedure or surgery | Tooth loss |
| Alveolar Prf graftTo enhance clot formation and promote angiogenesis and tissue regeneration, autologous platelet-rich fibrin (PRF) will be used in the recipient site. PRF Collection and Preparation * Prior to surgery, peripheral venous blood will be collected from the patient using sterile tubes without anticoagulants. * The blood samples will be immediately processed using a standardized centrifugation protocol, allowing the separation of a fibrin matrix enriched with platelets and leukocytes. * After centrifugation, the PRF clot will be gently removed and prepared under sterile conditions for clinical use. PRF Placement * The autologous PRF will be placed directly into the recipient alveolus before positioning the donor tooth. * The PRF matrix will act as a biological scaffold, promoting clot stabilization, neovascularization, and early healing of the periodontal and pulpal tissues. | Procedure or surgery | Tooth loss |
Primary outcome
Resporption
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Rx to evalue internal or external root resorption. Present or Not.
Vitality
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Pulp vitality will be assessed during follow-up using standardized sensibility tests. ( electric test). Vitality : Yes or None
Mobility
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Mobility Test. Grade I, Grade II or Grade III
Inflammation
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
signs of inflammation will be monitored. Blood on Probing: Yes or None
periodontal health
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Periodontal Chart (mm). 6 point for each tooth.
bone remodeling
Time frame: 1 month, 1 year, 2 years
Assess periodontal integration and bone remodeling by Rx. Comparing Rx.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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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.
Nicola De Giglio, Dr. contact
Giuseppe D'Albis, Dr. principal investigator
University of Bari Aldo Moro
Nicola De Giglio, Dr. principal investigator
University of Bari Aldo Moro
Saverio Capodiferro, Prof. Dr. study director
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous Tooth Transplantation and Alveolar Prf graft in people with Tooth Loss and Tooth Diseases, run by University of Bari Aldo Moro at 1 site in Italy.
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 14 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe D'Albis, Dr. (+393495103642, giuseppe.dalbis@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resporption (time frame: 1 month, 3 months, 6 months, 1 year, 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.