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临床试验/NCT06433375
NCT06433375已完成不适用

Evaluation of the Efficacy of Growth Hormone, EndoSeal MTA Sealer, and Their Combination on Healing of Periapical Pathosis(Non-Surgical Approach)

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年4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
28
试验地点
2
主要终点
Post operative CBCT scan

研究概览

简要总结

This study aimed to evaluate the effect of growth hormone, EndoSeal MTA sealer, and their combination on Healing of Periapical Pathosis.

详细描述

Out of 100 healthy male patients aged 18 to 40 years, 32 were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores 1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Single-rooted permanent teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Necrotic teeth with apical periodontitis.
  • Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
  • Teeth with mature apices, root canal curvature between (0-10º) according to Schneider(9) and radii of curvature between 2 to 5 mm according to Pruett would be included in the study(10).
  • Teeth with estimated working length of 20mm(±2mm) from the incisal edge as a reference point provided that the crown/root ratio was not compromised.
  • Non-critical sized periapical lesion related only to one tooth of a 2 to 4mm diameter and score 3 when evaluated using the Cone Beam Computed Tomography Periapical Index Score (CBCTPAI)(11) , Table (1) presents the scoring scale of CBCT-PAI.
  • Teeth located in anatomic areas in which enucleation of the periapical tissues may jeopardize nearby structures, such as the incisive foramen or nasal cavity should be at least 2 mm away from these structures.

排除标准

  • Necrotic teeth with related periapical swelling or sinus tract.
  • Teeth with previous root canal fillings and /or indirect coronal restoration.
  • Teeth with abnormal root canal anatomy.
  • Non-restorable teeth due to insufficient coronal tooth structure.
  • Teeth with periodontal disease.
  • Teeth with grade III mobility.
  • Teeth with clinical evidence of a missing buccal bony plate over the periapical defect.
  • Traumatized teeth with suspected root cracks, fractures, intrusive and extrusive injuries, previously avulsed or lateral luxation injuries.

结局指标

主要结局

Post operative CBCT scan

时间窗: 12 months

Evaluation of non surgical root canal tratment healing according to CBCTPAI

次要结局

  • Post operative pain assesment(1 week)

研究者

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

Mohamed Zakaria Abd El Aziz

Principal investigator

Al-Azhar University

研究点 (2)

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