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临床试验/NCT05863728
NCT05863728已完成不适用

Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Postoperative pain assessment

研究概览

简要总结

The aim of the study was to evaluate the effect of Piezosurgery and Trephine bur as cutting tools on post-operative sequelae including pain and swelling following guided endodontic microsurgeries.

详细描述

Materials and Methods

Twenty healthy male patients aged between 18 and 45 years old were selected in the study. Mandibular first molar teeth with failed non-surgical treatment or re-treatment due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument, and canal calcification were selected. Piezosurgery assisted cavity preparation and root-end resection were performed in Groups I and II, and Trephine bur assisted cavity and root-end resection was performed in Groups III and IV. An apical curettage was performed and the over-extended objects such as separated instruments or gutta percha were removed. The PRF clots was placed inside the bone cavity in groups I and III while the bone cavity was kept for 2 min to allow the blood clots to be formed in groups II and IV. The degree of pain and swelling were recorded for five days every 24, 48, 72, 96, and 120 hours postoperatively.

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
是

入选标准

  • •Mandibular first molar teeth were selected according to specific inclusion criteria including:
  • •Teeth presented with failed non-surgical treatment or re-treatment. Failure is due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument and canal calcification.
  • •Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
  • •Teeth presented without periapical radiolucency (Class A) or with periapical radiolucency not more than 1 mm in diameter both mesiodistally and buccolingually (Class B) according to the preoperative endodontic microsurgical classification of teeth.
  • •Teeth presented with non-fused mesial and distal roots and the mesial roots are range from 10 to 15 mm. in length, Type III root canal configuration (Two canals run separately from orifice to apex). The root canal curvature angle was measured using the Weine technique to be not less than 160° in both directions buccolingually and mesiodistally.
  • •At the apical 3 mm of the mesial radiographic root apex, the distance from the outer surface of the buccal cortical plate of bone to the buccal side of the mesial root is 1.5 mm (Depth I). The buccolingual dimension of the mesial root is 7 mm mm (Depth II). The distance from the lingual surface of the mesial root to the outer surface of the lingual cortical plate of bone is 3.5 mm. (Depth III).

排除标准

  • 未提供

研究组 & 干预措施

Piezosurgery assisted group

Experimental

A Piezosurgery assisted cavity preparation was performed using a IM4A Piezosurgery tip mounted in the handpiece of a Piezosurgery device (PIEZOSURGERY touch, Mectron, Carasco, Italy) at an operating frequency in the range of 24 to 36 kHz with power ratings 55 W for osteotomy and root-end resection

干预措施: Piezosurgery assisted group (Procedure)

Trephine Burs assisted group

Experimental

Trephine bur assisted cavity preparation was performed using a TPB-4 trephine bur mounted in 20:1 contra angled handpiece of an implant motor (ImplaNX, Micro-NX, Republic of Korea) at an operating speed in the range of 800 to 1200 / Torque 30 N for osteotomy and root-end resection

干预措施: Trephine Bur assisted group (Procedure)

结局指标

主要结局

Postoperative pain assessment

时间窗: 120 hours

The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).

Postoperative pain assessment

时间窗: 24 hours

The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).

Postoperative pain assessment

时间窗: 48 hours

The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).

Postoperative pain assessment

时间窗: 72 hours

The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).

Postoperative pain assessment

时间窗: 96 hours

The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).

次要结局

  • Postoperative swelling assessment(120 hours)
  • Postoperative swelling assessment(24 hours)
  • Postoperative swelling assessment(48 hours)
  • Postoperative swelling assessment(72 hours)
  • Postoperative swelling assessment(96 hours)

研究者

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

Mahmoud Yehia Abouel Naga

Principal Investigator/ Assistant Lecturer

Al-Azhar University

研究点 (1)

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