Actively Recruiting

Phase Not Applicable
Age: 10Years - 80Years
All Genders
Healthy Volunteers
ID07393997

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

Led by University of Bari Aldo Moro · Updated on 2026-02-06

5

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating autogenous tooth transplantation combined with simulated apical opening and autologous platelet-rich fibrin (PRF) in patients with complete root formation teeth. This approach aims to improve pulpal revascularization, reduce pulp necrosis, and enhance long-term outcomes for tooth loss cases where implant therapy is not suitable, especially in young patients with ongoing skeletal growth. The study explores a biologically driven method that integrates surgical and regenerative techniques to expand transplantation options. The treatment involves extracting the donor tooth atraumatically, then creating a simulated open apex using rotary instruments to encourage blood vessel regrowth inside the tooth. Autologous PRF, prepared from the patient's blood through centrifugation, is applied to the recipient site to support clot formation, tissue regeneration, and healing. The PRF acts as a scaffold to stabilize the clot and promote vascularization before placing the donor tooth into the alveolus. Participants will be monitored at multiple timepoints up to two years post-transplantation. Assessments include checking for tooth resorption, vitality, mobility, inflammation, periodontal health, and bone remodeling. The study tracks healing progress and biological outcomes to evaluate the success of this combined technique. Total participation duration spans at least two years, with evaluations at 1 month, 3 months, 6 months, 1 year, and 2 years after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 10 and 80 years
  • Early loss of permanent teeth due to trauma, extensive caries, or agenesis
  • Dental agenesis involving premolars or incisors with a suitable donor tooth
  • Replacement of non-restorable teeth such as fractures or destructive caries
  • Preservation of alveolar bone in growing patients where implants are 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 extracted for orthodontic purposes, impacted or erupting third molars with compatible morphology, or suitable supernumerary teeth
Not Eligible

You will not qualify if you...

  • Poor patient compliance
  • Active infection at the recipient site
  • Smoking more than 15 cigarettes a day
  • Untreated periodontal disease
  • Pregnancy or breastfeeding at date of inclusion
  • Acute infections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single surgical procedure with immediate post-operative period

Participants undergo autogenous tooth transplantation with instrumentally simulated open apex and autologous platelet-rich fibrin applied to the recipient site to promote healing and pulpal revascularization.

1 surgical visit (in-person)

Follow-up

Duration - Up to 2 years

Participants are monitored for clinical outcomes including tooth vitality, resorption, mobility, inflammation, periodontal health, and bone remodeling to assess the success of the transplantation.

Visits at 1 month, 3 months, 6 months, 1 year, and 2 years post-transplantation

Trial Site Locations

Total: 1 location

1

University of Bari Aldo Moro, Hospital

Bari, Italy, 70124

Actively Recruiting

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Research Team

G

Giuseppe D'Albis, Dr.

N

Nicola De Giglio, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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