CGF-Enhanced Autologous Pulp Transplantation in Mature Necrotic Teeth

NCT07314866 | Completed

• 2 other identifiers: KSU-CGF-PULP-2024KSU Ethics Committee Approval
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Necrosis; Apical Periodontitis

Keywords

Regenerative Endodontics; Autologous Pulp Transplantation; Concentrated Growth Factor; Pulp Necrosis; Periapical Periodontitis; Cone-Beam Computed Tomography; Mature Permanent Teeth

Outcome Measures

Primary Outcomes (1)

• Number of Teeth With Periapical Healing Assessed by CBCT

  Periapical healing will be assessed using cone-beam computed tomography (CBCT). Healing will be defined as complete or partial resolution of periapical radiolucency and evidence of bone regeneration at the root apex compared with baseline CBCT images. Outcomes will be reported as the number of treated teeth demonstrating radiographic periapical healing.

  12 months

Secondary Outcomes (2)

• Number of Teeth With Positive Pulp Sensibility Response Assessed by Electric Pulp Testing

  6 months and 12 months

• Number of Teeth With Clinical Success

  Up to 12 months

Study Arms (1)

CGF-Enhanced Autologous Pulp Transplantation

EXPERIMENTAL

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

Procedure: Autologous Pulp Transplantation With Concentrated Growth Factor

Interventions

Autologous Pulp Transplantation With Concentrated Growth Factor 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.

CGF-Enhanced Autologous Pulp Transplantation

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sutcu İmam University, Faculty of Dentistry

Kahramanmaraş, onikişubat, 46010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Aliye Kamalak

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endodontics

Model Details: All participants received the same regenerative intervention consisting of autologous pulp transplantation combined with concentrated growth factor, without a comparison or control group.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)