Evaluation of Different Scaffolds in Regenerative Endodontic Treatment of Immature Non-Vital Permanent Teeth and Their Release of Growth Factors: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Root Length
研究概览
简要总结
The aim of this study is to evaluate and compare the regenerative potentials of Injectable Platelet-Rich Fibrin (I-PRF), Platelet-Rich Fibrin (PRF), and Blood Clot (BC) as different scaffolds regarding:
Radiographic outcomes (increase of root length, increase in thickness of dentinal wall, healing of periapical lesion, and apical closure).
Clinical outcomes in the treatment of young, immature permanent teeth with necrotic pulps.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The trial design of this study is planned to be a double-blinded design in which the participant and the statistician will be blinded, and only the operator knows which treatment the patient will receive.
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Necrotic immature permanent anterior teeth.
- •Teeth not indicated for post/core final restoration.
- •Radiographically: The root has incomplete development with an apical opening of more than 1 mm.
排除标准
- •Medically compromised patients with blood and immunity disorders. Family history of autoimmune disorder. Also, patients with physical or mental handicapping conditions.
- •Teeth with questionable restorability of the remaining crown/root structure.
- •Pathological tooth mobility.
- •Radiographically: Evidence of root fracture or root resorption (external or internal).
研究组 & 干预措施
Regeneration with Injectable platelet-rich fibrin (i-PRF) scaffold
10 ml of venous blood was drawn from the patient's arm. Then it was collected in a sterile tube without anticoagulant.
- The collected blood was centrifuged immediately.
- The separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle and amounts to a partially active injectable form.
干预措施: Injectable platelet-rich fibrin (i-PRF) scaffold (Procedure)
Regeneration with platelet-rich fibrin (PRF)scaffold
10 ml venous blood was drawn from the patient's arm
- Then it was collected in a sterile tube without anticoagulant.
- The collected blood was centrifuged immediately.
- Following the centrifugation, the fibrin clot was formed in the middle of the tube between the red corpuscles at the bottom and acellular plasma at the top.
干预措施: platelet-rich fibrin (PRF)scaffold (Procedure)
Regeneration with blood clot (BC) scaffold
The file will be passed 2 mm beyond the apical end to induce bleeding inside the canal till approximately 2-3 mm below the CEJ.
干预措施: blood clot (BC) scaffold (Procedure)
结局指标
主要结局
Root Length
时间窗: 12 months
the distance between the CEJ and the apical endpoint mesially (M) and distally (D) on the coronal plane and labially (L) and palatally (P) on the sagittal plane. it was measured by a measure length tool in millimeters.
Root dentine thickness
时间窗: 12 months
Root dentine thickness was measured as a line from the outer root canal diameter to the canal lumen in the mesial, distal, buccal, and lingual dentinal walls of the root. It was measured from the axial plane at 4 mm and 8 mm from the CEJ. It was measured by the same length-measuring tool in millimeters.
Apical foramen diameter
时间窗: 12months
It was measured as a line from the mesial and distal root ends at the coronal plane and from the labial to palatal root ends at the sagittal plane in millimeters.
Bony lesion volume
时间窗: 12 months
The volume of each slice of the lesion was calculated by multiplying the area of each cut by the distance of 0.5mm between the tomographic sections. With the sum of the volume of all the slices, the total volume of the bony lesion was obtained in cubic centimeters.
次要结局
- Pulp sensibility(12 months)
研究者
Riham Karam Ahmed
Ass.Lecturer
British University In Egypt