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临床试验/NCT04606719
NCT04606719已完成不适用

Healing Potentiality Of Blood Clot, S-PRF and A-PRF As Scaffold In Treatment Of Non-Vital Mature Single Rooted Teeth With Chronic Peri-Apical Periodontitis Following Regenerative Endodontic Therapy (Randomized Clinical Trial)

Cairo University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
healing Rate

研究概览

简要总结

Earlier, it was believed that successful regeneration cannot be achieved once tooth has become infected. However, recent studies suggest that regenerative endodontics may in fact be possible in teeth with pulpal necrosis and periapical pathology.

The primary goal in regenerative procedure is to eliminate clinical symptoms and resolve apical periodontitis. The blood clot acts as a scaffold, and the growth factors inside recruit stem cells, most likely from periapical papilla. But unfortunately, the erythrocytes in the clot of the blood column undergo necrosis, affecting its properties so the blood column is augmented by the use of different types of scaffolds.

Platelet-rich fibrin is classified into four types (Standard PRF, Injectable PRF, Advanced PRF and Concentrated Growth Factor CGF) according to speed and time of centrifuge with the overall aim to increase the number of platelets and leucocytes

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

double blinded

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically free patients who accept to participate in the study.
  • Age between 18-35 years old with no sex predilection.
  • Patients with good oral hygiene.
  • Patients with necrotic pulp in mandibular & maxillary single rooted permanent teeth with mature apex that Symptomatic or Asymptomatic , Doesn't respond positively with the electric pulp tester ,Associated with or without swelling /sinus tract, Has radiographic evidence of periapical radiolucency, Has a straight, non-curved root, Teeth with normal occlusal contact with the opposing teeth.

排除标准

  • Illiterate patient because they can't estimate the pain level on the pain scale (NRS).
  • Patients with systemic diseases or on systemic corticosteroids therapy because they have impaired healing and higher incidence of pain.
  • Pregnant women to avoid radiation exposure during the treatment which may be hazardous to the fetus and breasts from dental X-ray examinations shields.
  • Patients that have allergy to ciprofloxacin or metronidazole to avoid any allergic reaction after placement of bi-antibiotic paste as intra-canal medication.
  • Patients reporting bruxism or clenching because this induce more pressure on teeth and may initiate the post-operative pain in the treated tooth which is already have peri-apical inflammation
  • Teeth that, Have vertical root fracture, coronal perforation, and calcification, Are indicated for retreatment because they have lower success rate , Have pocket depth greater than 5mm,Need periodontal therapy , Non restorable , Hopeless tooth, patients that have T.M.J disorder

结局指标

主要结局

healing Rate

时间窗: follow up to 6 months

standardized digital radiograph

次要结局

  • Postoperative pain: NRS(up to one year)
  • sensitivty(6 months to one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omnia Badawy Darwish

Principal Investigator

Cairo University

研究点 (2)

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