Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin Versus Root Canal Treatment in Mature Permanent Molars With Apical Periodontitis: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Clinical success
研究概览
简要总结
Study aimed at assessing the clinical and radiographic success of pulp regeneration using injectable platelet-rich fibrin in mature permanent molars with apical periodontitis versus root canal treatment using Gutta Percha (GP) obturation.
详细描述
Randomized pilot study, parallel groups design with 1:1 allocation ratio.
PICOT:
Population: Mature first permanent molar with apical periodontitis. Intervention: Regeneration using injectable platelet-rich fibrin. Control: Root canal treatment using GP obturation. outcomes: clinical and radiographic success. Source of patients: this study will be conducted in the outpatient postgraduate clinic of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University, Egypt.
Written Informed consent from participating children/parents. Baseline records photographs, clinical inspection, percussion test, periapical radiograph, and personal data collection will be conducted.
A diagnostic chart with personal, medical, and dental history will be filled Diagnosis and treatment of the cases will be performed according to the Treatment Standards of the American Association of Endodontists (AAE) 2020 of Non-Surgical Endodontics for the Uncomplicated Mature Permanent Teeth.
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)
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 10-15 years.
- •First Permanent molar diagnosed with apical periodontitis.
- •A cooperative and compliant patient/ parent.
- •Patients not allergic to medicaments necessary to complete the procedure.
- •Patients with no history of chronic systemic diseases.
排除标准
- •Teeth indicated for post and core.
- •Non-restorable tooth.
- •Previous root canal treatment.
- •Curved canal of more than 25°.
- •Periodontal pocket larger than 3 mm.
- •Teeth with developmental anomalies.
研究组 & 干预措施
Regeneration using Injectable platelet-rich fibrin
A 10-mL sample of whole venous blood will be drawn from the patient's forearm (median cubital vein). It will be centrifuged immediately by a tabletop centrifuge at 700 rpm for 3 minutes at room temperature. Injectable platelet-rich fibrin (I-PRF) will be collected. After that, the I-PRF will be injected inside the canals using a plastic syringe needle that will be placed 1mm short of the working length and withdrawn gradually while injecting till reaching the orifices of the canals. After that, a Collagen membrane matrix will be placed above the canal orifice and will left for 5 minutes to partially harden, then a 3 mm thick layer of MTA will be placed directly over it. The cavity will be sealed with composite and covered with a stainless steel crown.
干预措施: Regeneration using Injectable platelet-rich fibrin (Procedure)
Root canal treatment
The root canal will be obturated with gutta-percha by the cold lateral condensation technique with epoxy resin-based root canal sealer, the cavity will be sealed with composite and covered with a stainless steel crown.
干预措施: Root canal treatment (Procedure)
结局指标
主要结局
Clinical success
时间窗: 1, 3, 6, 9 and 12 months
Clinical Success is a composite outcome and will be recorded as Clinically Successful or Clinically Unsuccessful based on the following evaluation criteria: Clinically Successful: Following assigned treatment in case of absence of all of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain. Clinically unsuccessful: Following assigned treatment in case of presence of any of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.
次要结局
- Radiographic success(6 and 12 months)
- Overall success(6 and 12 months)
研究者
Samah Mohsen Kanzel
Pediatric Dentist
Cairo University