Kahramanmaraş Sutcu İmam University, Faculty of Dentistry
Kahramanmaraş, onikişubat, 46010, Turkey (Türkiye)
NCT Number: NCT07314866
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.
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Notify Me15 year–40 year
All sexes
Interventional
Not applicable
Kahramanmaraş, onikişubat, 46010, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months
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.
Time frame: 6 months and 12 months
Pulp sensibility will be evaluated using electric pulp testing (EPT). A positive response will be defined as the presence of a reproducible sensibility response compared with baseline measurements. Outcomes will be reported as the number of treated teeth demonstrating a positive pulp sensibility response at follow-up.
Time frame: Up to 12 months
Clinical success will be defined as the absence of clinical signs and symptoms, including pain, swelling, sinus tract, tenderness to percussion or palpation, abnormal mobility, and loss of tooth function. Outcomes will be reported as the number of treated teeth meeting all clinical success criteria during follow-up visits.
Kahramanmaras Sutcu Imam University
Other
Clinical and Radiographic Outcomes of CGF-Enhanced Autologous Pulp Transplantation in Necrotic Mature Teeth: A Pilot Clinical Study
Acronym: CGF-PULP
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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