Clinical and Radiographic Outcomes of CGF-Enhanced Autologous Pulp Transplantation in Necrotic Mature Teeth: A Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Teeth With Periapical Healing Assessed by CBCT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Teeth With Periapical Healing Assessed by CBCT
时间窗: 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.
次要结局
- 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)
研究者
Aliye Kamalak
Associate Professor of Endodontics
Kahramanmaras Sutcu Imam University