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NCT Number: NCT07393997

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

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.

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Key information

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bari Aldo Moro, Hospital

Bari, 70124, Italy

Location status: Recruiting

Location contact

Giuseppe D'Albis, Dr.

CONTACT

Giuseppe D'Albis, Dr.

PRINCIPAL_INVESTIGATOR

Nicola De Giglio, Dr.

CONTACT

[email protected]

Nicola De Giglio, Dr.

PRINCIPAL_INVESTIGATOR

Saverio Capodiferro, Prof. Dr.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autogenous Tooth Transplantation

Procedure

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.

Alveolar Prf graft

Procedure

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.

Primary outcomes

  1. Resporption

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

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

  2. 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

  3. Mobility

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

    Mobility Test. Grade I, Grade II or Grade III

  4. 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

  5. periodontal health

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

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

  6. bone remodeling

    Time frame: 1 month, 1 year, 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe D'Albis, Dr.

CONTACT

[email protected]

+393495103642

Nicola De Giglio, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Bari Aldo Moro

Other

Registry information

Official study 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

Acronym: OpenApexT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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