Application of Platelet-Rich Fibrin (PRF) in Revascularisation of Immature Permanent Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Apical Closure
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of an advanced platelet-rich fibrin plus (A-PRF+) revascularization procedure to promote healing and root development in necrotic immature permanent single-rooted teeth in children and adolescents aged 8 to 18 years.
The main questions it aims to answer are:
- Does the A-PRF+ protocol improve root length, dentinal wall thickness, and apical closure compared to traditional calcium hydroxide apexification treatment?
- Does A-PRF+ promote restoration of pulp vitality and reduce clinical symptoms such as pain, inflammation, or tooth discoloration? Results from the A-PRF+ treatment group will be compared with those from a historical control group receiving traditional calcium hydroxide apexification to evaluate relative effectiveness.
Participants will:
- Receive treatment following the A-PRF+ protocol, which includes disinfecting the tooth canal, applying an autologous platelet-rich fibrin scaffold, and sealing with glass ionomer cement;
- Undergo clinical and radiographic follow-up visits at 1, 3, 6, 9, and 12 months;
- Have pulp vitality tested with cold, electric, and laser Doppler flowmetry methods;
- Be monitored for clinical symptoms, healing progress, and restoration performance.
This study will help determine whether A-PRF+ is a safe and effective alternative to conventional apexification for regenerating necrotic immature teeth in young patients.
详细描述
This study is a prospective interventional clinical trial evaluating an advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol compared to a historical control group treated with traditional calcium hydroxide apexification for necrotic immature permanent single-rooted teeth in children and adolescents aged 8 to 18 years.
The main goal is to assess the regenerative effectiveness of the A-PRF+ protocol in promoting root development, including root lengthening, dentinal wall thickening, and apical closure, compared to conventional apexification. Secondary objectives include evaluating pulp vitality restoration and monitoring clinical outcomes such as symptom resolution, tooth survival, and adverse effects like tooth discoloration.
Participants in the experimental group were prospectively enrolled and received treatment involving minimal mechanical instrumentation, canal disinfection with sodium hypochlorite, intracanal calcium hydroxide medicament, followed by triple antibiotic paste. At the final appointment, autologous A-PRF+ was prepared from peripheral blood and applied as an intracanal scaffold extending into the coronal cavity, sealed permanently with glass ionomer cement.
The control group consists of patients previously treated at the same institution with calcium hydroxide apexification. Their clinical and radiographic records were retrospectively reviewed for comparison. Apexification was not performed as part of this study.
Clinical and radiographic follow-ups were conducted at 1, 3, 6, 9, and 12 months, including pulp vitality testing with cold, electric, and laser Doppler flowmetry methods, along with standardized periapical radiographs to measure root length, dentinal wall thickness, and apical diameter. Restoration quality was assessed using modified USPHS criteria.
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
盲法说明
While this is an open-label trial with no masking of participants, care providers, investigators, or outcome assessors, radiographic images were randomly coded and evaluated by blinded independent examiners to reduce measurement bias and improve objectivity. Additionally, the control group consisted of randomly selected historical patient records to enhance the validity of comparisons. Follow-up assessments were conducted by independent clinicians who were not involved in the initial treatments, further minimizing examiner bias.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 8 to 18 years presenting with immature permanent single-rooted teeth with necrotic pulp caused by caries or dental trauma
- •Preserved tooth crown
- •Negative response to cold and electric pulp tests
- •Radiographic evidence of incomplete root development (Cvek stages I-IV)
- •Apical diameter greater than 0.5 mm
排除标准
- •Presence of systemic illness or allergies to treatment components
- •Complicated crown or root fractures
- •Evidence of ankylosis or root resorption
- •Ongoing orthodontic treatment
- •Inability to comply with follow-up appointments (e.g., needle phobia or poor cooperation)
- •Subsequent trauma to the treated tooth during the study period
- •Missed recall appointments
研究组 & 干预措施
Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Group
Participants receive the advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol. This involves minimal mechanical instrumentation, canal disinfection with sodium hypochlorite, intracanal medicaments including calcium hydroxide and triple antibiotic paste, followed by placement of autologous A-PRF+ scaffold extending into the coronal cavity. The cavity is then permanently sealed with glass ionomer cement.
干预措施: Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure (Procedure)
结局指标
主要结局
Apical Closure
时间窗: From enrollment through 12 months post-treatment
Apical closure was assessed by measuring the reduction in apical diameter on standardized periapical radiographs. Radiographs were consistently acquired using a film holder to minimize angulation differences and distortion. Two independent blinded examiners used diagnostic software with 0.1 mm precision to measure the distance across the apical foramen. Changes from baseline to follow-up at 12 months were used to quantify apical closure.
Root Lengthening
时间窗: From enrollment through 12 months post-treatment
Root lengthening was assessed by measuring the linear distance from the cementoenamel junction (CEJ) to the radiographic apex on standardized periapical radiographs. Radiographs were obtained using a film holder to ensure consistent angulation and minimize distortion. Measurements were performed using diagnostic software with a precision of 0.1 mm by two independent blinded examiners. The change from baseline to follow-up measurements over the 12-month period was calculated to quantify root lengthening.
Dentinal Wall Thickening
时间窗: From enrollment through 12 months post-treatment
Dentinal wall thickening was evaluated by measuring the increase in dentinal wall width at the coronal two-thirds of the root on standardized periapical radiographs. Radiographs were obtained using a film holder to ensure reproducible angulation and reduce distortion. Two blinded examiners independently performed measurements using diagnostic software with an accuracy of 0.1 mm. The difference between baseline and follow-up measurements over 12 months quantified dentinal wall thickening.
次要结局
- Pulp Vitality Responses(From enrollment through 12 months post-treatment)
- Presence of Periapical Pathology(From enrollment through 12 months post-treatment)
- Clinical Evaluation of Restorations Using Modified USPHS Criteria(From enrollment through 12 months post-treatment)
- Tooth Survival(From enrollment through 12 months post-treatment)
研究者
Dubravka Turjanski, Dr. Dent. Med.
Dr. Dent. Med.
University of Zagreb