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

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.

Study Overview

• Status: Recruiting
• Conditions: Tooth Diseases; Tooth Loss; Reimplant; Complications
• Intervention / Treatment: Procedure: Autogenous Tooth Transplantation; Procedure: Alveolar Prf graft

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 Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe D'Albis, Dr.; Phone Number: +393495103642; Email: giuseppe.dalbis@uniba.it
• Study Contact Backup: Name: Nicola De Giglio, Dr.; Email: nicola.degiglio@uniba.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • University of Bari Aldo Moro, Hospital
    • Contact: Giuseppe D'Albis, Dr.
    • Contact: Nicola De Giglio, Dr.; Email: giuseppe.dalbis@uniba.it
    • Principal Investigator: Giuseppe D'Albis, Dr.
    • Principal Investigator: Nicola De Giglio, Dr.
    • Principal Investigator: Saverio Capodiferro, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 contraindicated.
• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tooth loss; Patients presenting with hopeless teeth

Procedure: Autogenous 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.; Procedure: Alveolar 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resporption	Rx to evalue internal or external root resorption. Present or Not.	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	1 month, 3 months, 6 months, 1 year, 2 years
Mobility	Mobility Test. Grade I, Grade II or Grade III	1 month, 3 months, 6 months, 1 year, 2 years
Inflammation	signs of inflammation will be monitored. Blood on Probing: Yes or None	1 month, 3 months, 6 months, 1 year, 2 years
periodontal health	Periodontal Chart (mm). 6 point for each tooth.	1 month, 3 months, 6 months, 1 year, 2 years
bone remodeling	Assess periodontal integration and bone remodeling by Rx. Comparing Rx.	1 month, 1 year, 2 years

Collaborators and Investigators

• Sponsor: University of Bari Aldo Moro
• Investigators: Principal Investigator: Giuseppe D'Albis, Dr., University of Bari Aldo Moro; Study Director: Saverio Capodiferro, Prof. Dr., University of Bari Aldo Moro; Principal Investigator: Nicola De Giglio, Dr., University of Bari Aldo Moro

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Loss; Tooth Diseases
• Other Study ID Numbers: OpenApexTechnique

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No