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

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

Overview

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

• 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 centrif

Primary outcome measures

• Resporption [Time frame: 1 month, 3 months, 6 months, 1 year, 2 years]
• Vitality [Time frame: 1 month, 3 months, 6 months, 1 year, 2 years]
• Mobility [Time frame: 1 month, 3 months, 6 months, 1 year, 2 years]
• Inflammation [Time frame: 1 month, 3 months, 6 months, 1 year, 2 years]
• periodontal health [Time frame: 1 month, 3 months, 6 months, 1 year, 2 years]
• bone remodeling [Time frame: 1 month, 1 year, 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• University of Bari Aldo Moro, Hospital — Bari

Identifiers

NCT: NCT07393997 · OpenApexTechnique

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗