Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07314866
Status:
COMPLETED
Last Update Posted:
2026-01-07
First Post:
2025-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CGF-Enhanced Autologous Pulp Transplantation in Mature Necrotic Teeth
Sponsor:
Kahramanmaras Sutcu Imam University
Organization:
Study Overview
Official Title:
Clinical and Radiographic Outcomes of CGF-Enhanced Autologous Pulp Transplantation in Necrotic Mature Teeth: A Pilot Clinical Study
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CGF-PULP
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KSU Ethics Committee Approval | OTHER | 02/05.11.2025 | View |