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

NCT07393997 | Recruiting

• 1 other identifier: OpenApexTechnique
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Loss; Tooth Diseases; Reimplant; Complications

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Tooth loss

EXPERIMENTAL

Patients presenting with hopeless teeth

Procedure: Autogenous Tooth Transplantation; Procedure: Alveolar Prf graft

Interventions

Autogenous Tooth Transplantation PROCEDURE

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.

Tooth loss

Alveolar Prf graft PROCEDURE

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.

Tooth loss

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Poor patient compliance.
• Active infection at the recipient site.
• Smoking of more than 15 cigarettes a day
• . Untreated periodontal disease
• Acute infections

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

University of Bari Aldo Moro, Hospital

Bari, 70124, Italy

RECRUITING

MeSH Terms

Conditions

Tooth Loss; Tooth Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Giuseppe D'Albis, Dr.

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

• Nicola De Giglio, Dr.

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

• Saverio Capodiferro, Prof. Dr.

  University of Bari Aldo Moro

  STUDY DIRECTOR

Central Study Contacts

Giuseppe D'Albis, Dr.

CONTACT

+393495103642; giuseppe.dalbis@uniba.it

Nicola De Giglio, Dr.

CONTACT

nicola.degiglio@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 6, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

IT (1)