Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Pulp Vitality Recovery Assessed by Electric Pulp Test
研究概览
简要总结
This randomized clinical trial aims to compare autologous dental pulp transplantation alone or combined with concentrated growth factor (CGF) with conventional root canal treatment in necrotic mature teeth with periapical radiolucency. The primary objective is to evaluate whether autologous pulp transplantation can facilitate the return of vitality in necrotic teeth. A secondary objective is to assess whether the addition of CGF provides any further clinical benefit.
Twenty-one patients with single-rooted teeth presenting with periapical lesions are randomly allocated into three groups (n = 7 per group): Group 1 receives autologous pulp transplantation, Group 2 receives pulp transplantation combined with CGF, and Group 3 receives conventional root canal treatment. Donor pulp tissue is obtained from the patient's own non-carious third molars. Clinical and radiographic follow-up is planned at 3, 6, and 12 months, including electrical pulp testing, periapical radiographs, and cone-beam computed tomography (CBCT).
详细描述
This study investigates the clinical applicability of autologous dental pulp transplantation as a potential biologic treatment alternative for necrotic mature teeth with periapical radiolucency. The trial explores whether transplantation of the patient's own pulp tissue, with or without the addition of concentrated growth factor (CGF), can promote tissue regeneration and functional recovery. The design includes three treatment groups to evaluate the effects of pulp transplantation alone, pulp transplantation combined with CGF, and conventional root canal therapy.
Participants are adults presenting with single-rooted teeth diagnosed with pulp necrosis and periapical pathology. Following randomization, the allocated intervention is performed under standardized clinical protocols. Donor pulp tissue is harvested atraumatically from non-carious third molars of the same patient. Outcome assessments include vitality testing and radiographic evaluations at predetermined follow-up intervals. The study aims to provide foundational clinical evidence regarding the feasibility, safety, and regenerative potential of autologous pulp transplantation techniques to inform future clinical applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome evaluations and statistical analyses were performed by blinded examiners independent of the clinical operators.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-40 years
- •Presence of single-rooted permanent teeth diagnosed with:
- •Pulp necrosis or
- •Irreversible pulpitis with radiographic periapical lesions
- •Availability of a caries-free, periodontally healthy third molar suitable for donor pulp harvesting
- •Good general health, with no systemic diseases
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Multi-rooted teeth or teeth with complex canal anatomy
- •Systemic diseases or medical conditions that may affect wound healing (e.g., diabetes, immunosuppression)
- •Lack of a suitable donor third molar for pulp harvesting
- •Advanced periodontal attachment loss or active periodontal disease
- •Pregnancy or lactation
- •Recent use of antibiotics or anti-inflammatory drugs (<1 month)
- •Inability or unwillingness to attend scheduled follow-ups
结局指标
主要结局
Pulp Vitality Recovery Assessed by Electric Pulp Test
时间窗: 12 months after treatment
Assessment of the percentage of treated teeth exhibiting a positive response to the Electric Pulp Test, indicating return of pulp vitality (revascularization or functional regeneration). Unit of Measure: % of teeth with positive EPT response Measurement Tool: Electric Pulp Test (EPT)
次要结局
- Adverse Events Related to Transplantation Procedures(Throughout 12-month follow-up period)
- Pulp Vitality Recovery(12 months after treatment)
研究者
Aliye Kamalak
Assoc Prof
Kahramanmaras Sutcu Imam University