CGF-Enhanced Autologous Pulp Transplantation in Mature Necrotic Teeth

NCT ID: NCT07314866

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-09-01

Brief Summary

This pilot clinical study evaluated the clinical, radiographic, and functional outcomes of autologous pulp transplantation combined with concentrated growth factor (CGF) in mature permanent teeth with pulp necrosis and periapical lesions. Treated teeth were followed for 12 months using clinical examination, electric pulp testing, and cone-beam computed tomography to assess pulp sensibility and periapical healing.

Detailed Description

Regenerative endodontic treatment in mature necrotic permanent teeth remains challenging due to limited stem cell recruitment, restricted apical blood supply, and reduced regenerative capacity compared with immature teeth. Although regenerative approaches have shown promising results, achieving predictable outcomes in mature teeth continues to be a clinical concern.

This pilot clinical study aimed to evaluate the clinical, radiographic, and functional outcomes of autologous pulp transplantation enhanced with concentrated growth factor (CGF) in mature permanent teeth diagnosed with pulp necrosis and periapical lesions. The study was designed as an exploratory investigation to generate preliminary clinical evidence and guide future prospective controlled trials.

Eligible patients were systemically healthy individuals presenting with mature single-rooted permanent teeth requiring endodontic treatment. Autologous pulp tissue was harvested from extracted third molars and transplanted into disinfected root canals following a standardized regenerative protocol. Concentrated growth factor was prepared from the patient's venous blood and applied as a biologically active scaffold to support cell viability, angiogenesis, and tissue integration. Mineral trioxide aggregate was placed coronally to achieve an adequate seal.

Clinical outcomes were evaluated based on the absence of pain, swelling, sinus tract formation, or other postoperative complications, as well as preservation of tooth function. Functional recovery was assessed using electric pulp testing, and periapical healing was evaluated radiographically using cone-beam computed tomography. Patients were followed for up to 12 months after treatment.

Due to the exploratory nature and limited sample size of this pilot study, outcomes were analyzed descriptively. The findings are intended to provide preliminary clinical insight into the potential role of CGF-enhanced autologous pulp transplantation as a biologically driven regenerative approach for mature necrotic teeth.

Conditions

Pulp Necrosis; Apical Periodontitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CGF-Enhanced Autologous Pulp Transplantation

Participants received autologous pulp transplantation harvested from extracted third molars combined with concentrated growth factor as a regenerative endodontic treatment.

Group Type: EXPERIMENTAL

Autologous Pulp Transplantation With Concentrated Growth Factor

Intervention Type: PROCEDURE

Autologous pulp tissue harvested from extracted third molars was transplanted into disinfected root canals of mature necrotic permanent teeth. Concentrated growth factor prepared from the patient's venous blood was applied as a biologically active scaffold to support cell survival, angiogenesis, and tissue integration. The procedure was completed with coronal sealing using mineral trioxide aggregate.

Interventions

Autologous Pulp Transplantation With Concentrated Growth Factor

Autologous pulp tissue harvested from extracted third molars was transplanted into disinfected root canals of mature necrotic permanent teeth. Concentrated growth factor prepared from the patient's venous blood was applied as a biologically active scaffold to support cell survival, angiogenesis, and tissue integration. The procedure was completed with coronal sealing using mineral trioxide aggregate.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Systemically healthy patients aged 15 to 40 years.
• Mature permanent single-rooted teeth with clinical and radiographic diagnosis of pulp necrosis (or irreversible pulpitis with necrotic findings) associated with periapical radiolucency.
• Probing depth < 3 mm and no abnormal tooth mobility.
• No previous endodontic treatment or apical surgery on the study tooth.
• Availability of an autologous donor tooth (impacted or nonfunctional third molar indicated for extraction) to obtain pulp tissue.
• Ability and willingness to attend follow-up visits and provide written informed consent.

Exclusion Criteria

• Systemic conditions that may impair healing (e.g., uncontrolled diabetes mellitus, autoimmune disease) or use of immunosuppressive therapy.
• History of head and neck radiotherapy.
• Pregnancy or lactation.
• Poor oral hygiene or periodontal disease with probing depth ≥ 4 mm.
• Teeth with root fracture, internal/external root resorption, severe canal calcification, or non-restorable crown destruction.
• Inability to comply with follow-up schedule.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Aliye Kamalak

Associate Professor of Endodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aliye Kamalak

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Locations

Kahramanmaraş Sutcu İmam University, Faculty of Dentistry

Kahramanmaraş, onikişubat, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KSU Ethics Committee Approval

Identifier Type: OTHER

Identifier Source: secondary_id

KSU-CGF-PULP-2024

Identifier Type: -

Identifier Source: org_study_id