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Clinical Trials/NCT07393997
NCT07393997RecruitingNot Applicable

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

University of Bari Aldo Moro1 site in 1 country5 target enrollmentStarted: January 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
5
Locations
1
Primary Endpoint
Resporption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Tooth loss

Experimental

Patients presenting with hopeless teeth

Intervention: Autogenous Tooth Transplantation (Procedure)

Tooth loss

Experimental

Patients presenting with hopeless teeth

Intervention: Alveolar Prf graft (Procedure)

Outcomes

Primary Outcomes

Resporption

Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years

Rx to evalue internal or external root resorption. Present or Not.

Vitality

Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years

Pulp vitality will be assessed during follow-up using standardized sensibility tests. ( electric test). Vitality : Yes or None

Mobility

Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years

Mobility Test. Grade I, Grade II or Grade III

Inflammation

Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years

signs of inflammation will be monitored. Blood on Probing: Yes or None

periodontal health

Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years

Periodontal Chart (mm). 6 point for each tooth.

bone remodeling

Time Frame: 1 month, 1 year, 2 years

Assess periodontal integration and bone remodeling by Rx. Comparing Rx.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Bari Aldo Moro
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Giuseppe D'Albis

Principal Investigator

University of Bari Aldo Moro

Study Sites (1)

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