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RecruitingNCT07393997OpenApexTUpdated Feb 6, 2026

Autogenous Tooth Transplantation With Instrumentally Simulated Open Apex and Platelet-Rich Fibrin

An interventional study of Autogenous Tooth Transplantation and Alveolar Prf graft in Tooth Loss, Tooth Diseases and Reimplant; Complications, sponsored by University of Bari Aldo Moro. Recruiting at 1 site in Italy. Open to participants aged 10 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by University of Bari Aldo Moro · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
10 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Tooth Loss
  • Tooth Diseases
  • Reimplant; Complications
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 5 is below the median of 30 across 120 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

University of Bari Aldo Moro is the lead sponsor of 30 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 .
  • Functional and aesthetic rehabilitation of anterior teeth in pediatric and adolescent patients.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Tooth loss

    Patients presenting with hopeless teeth

    Procedure: Autogenous Tooth Transplantation · Procedure: Alveolar Prf graft

Interventions

  • ProcedureAutogenous Tooth Transplantation

    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.

  • ProcedureAlveolar Prf graft

    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.

06

What researchers measure

Primary outcomes

  1. Resporption

    Rx to evalue internal or external root resorption. Present or Not.

    Time frame: 1 month, 3 months, 6 months, 1 year, 2 years

  2. Vitality

    Pulp vitality will be assessed during follow-up using standardized sensibility tests. ( electric test). Vitality : Yes or None

    Time frame: 1 month, 3 months, 6 months, 1 year, 2 years

  3. Mobility

    Mobility Test. Grade I, Grade II or Grade III

    Time frame: 1 month, 3 months, 6 months, 1 year, 2 years

  4. Inflammation

    signs of inflammation will be monitored. Blood on Probing: Yes or None

    Time frame: 1 month, 3 months, 6 months, 1 year, 2 years

  5. periodontal health

    Periodontal Chart (mm). 6 point for each tooth.

    Time frame: 1 month, 3 months, 6 months, 1 year, 2 years

  6. bone remodeling

    Assess periodontal integration and bone remodeling by Rx. Comparing Rx.

    Time frame: 1 month, 1 year, 2 years

07

Study locations

1 of 1 sites recruiting
  • University of Bari Aldo Moro, Hospital
    Bari, 70124, Italy
    Recruiting
    • Giuseppe D'Albis, Dr. · Contact
    • Nicola De Giglio, Dr. · Contactgiuseppe.dalbis@uniba.it
    • Giuseppe D'Albis, Dr. · Principal investigator
    • Nicola De Giglio, Dr. · Principal investigator
    • Saverio Capodiferro, Prof. Dr. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07393997
Lead sponsor
University of Bari Aldo Moro
Responsible party
Giuseppe D'Albis (Principal Investigator, University of Bari Aldo Moro) — Principal investigator
First posted
Feb 6, 2026
Start date
Jan 1, 2026
Primary completion
Apr 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Feb 6, 2026

Study contacts

Giuseppe D'Albis, Dr.
Contact
giuseppe.dalbis@uniba.it
+393495103642
Nicola De Giglio, Dr.
Contact
nicola.degiglio@uniba.it
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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