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

Clinical Evaluation of Autogenous Tooth Transplantation With Instrumentally Simulated Open Apex and Autologous Platelet-Rich Fibrin (PRF) Support in Teeth With Complete Root Formation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07393997
Acronym
OpenApexT
Enrollment
5
Registered
2026-02-06
Start date
2026-01-01
Completion date
2026-09-01
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reimplant; Complications, Tooth Diseases, Tooth Loss

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.

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.

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.

Sponsors

University of Bari Aldo Moro
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Resporption1 month, 3 months, 6 months, 1 year, 2 yearsRx to evalue internal or external root resorption. Present or Not.
Vitality1 month, 3 months, 6 months, 1 year, 2 yearsPulp vitality will be assessed during follow-up using standardized sensibility tests. ( electric test). Vitality : Yes or None
Mobility1 month, 3 months, 6 months, 1 year, 2 yearsMobility Test. Grade I, Grade II or Grade III
Inflammation1 month, 3 months, 6 months, 1 year, 2 yearssigns of inflammation will be monitored. Blood on Probing: Yes or None
periodontal health1 month, 3 months, 6 months, 1 year, 2 yearsPeriodontal Chart (mm). 6 point for each tooth.
bone remodeling1 month, 1 year, 2 yearsAssess periodontal integration and bone remodeling by Rx. Comparing Rx.

Countries

Italy

Contacts

CONTACTGiuseppe D'Albis, Dr.
giuseppe.dalbis@uniba.it+393495103642
CONTACTNicola De Giglio, Dr.
nicola.degiglio@uniba.it
PRINCIPAL_INVESTIGATORGiuseppe D'Albis, Dr.

University of Bari Aldo Moro

PRINCIPAL_INVESTIGATORNicola De Giglio, Dr.

University of Bari Aldo Moro

STUDY_DIRECTORSaverio Capodiferro, Prof. Dr.

University of Bari Aldo Moro

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026