Autotransplantation of a patient's own tooth using 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
We will try transplanting patients' own fully developed teeth using a simulated open apex technique plus platelet-rich fibrin to encourage revascularization and help younger people or others who cannot get implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 10 Years to 80 Years |
| Sex | All |
| Sponsor | University of Bari Aldo Moro Academic / other |
| Locations | 1 site (Bari) |
| Trial ID | NCT07393997 on ClinicalTrials.gov |
What this trial studies
Autogenous tooth transplantation replaces a lost tooth with one of the patient's own teeth, preserving alveolar bone volume and periodontal proprioception. Teeth with complete root formation often fail to revascularize after transplantation, commonly resulting in pulp necrosis and the need for root canal treatment. This protocol combines instrumentally simulated apical patency with autologous platelet-rich fibrin (PRF) placed at the recipient site to promote pulpal revascularization and enhance tissue healing. Patients will undergo surgical transplantation with these adjuncts and be followed clinically and radiographically to compare rates of pulp necrosis and long-term success.
Who should consider this trial
Good fit: Ideal candidates are young patients or adolescents with early loss of permanent teeth from trauma, extensive caries, agenesis, or non-restorable fractures who have a suitable donor tooth with a healthy periodontal ligament and an adequate, infection-free recipient site.
Not a fit: Patients without a suitable donor tooth, with active infection at the recipient site, poor general or oral health, or those for whom implant therapy is appropriate are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could let more patients keep a natural tooth, preserve jaw bone and sensation, and reduce the need for implants or extensive root canal treatments.
How similar studies have performed: Autotransplantation is an established option in growing patients and PRF has shown healing benefits, but combining instrumentally simulated open apex with PRF for mature-root teeth is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bari
- University of Bari Aldo Moro, Hospital — Bari, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe D'Albis, Dr. — University of Bari Aldo Moro
- Study coordinator: Giuseppe D'Albis, Dr.
- Email: giuseppe.dalbis@uniba.it
- Phone: +393495103642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.