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临床试验/NCT06642415
NCT06642415招募中不适用

Effect Of High Magnification On Quality Of Life And Success After Endodontic Microsurgery: A Randomized Controlled Trial

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年11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
招募中
入组人数
40
试验地点
1
主要终点
Healing assessment

研究概览

简要总结

Effect of high magnification on quality of life and success after endodontic surgery: a randomized controlled trial"

详细描述

: Residual infection in untreated canal space is one of the most common cause of post treatment apical periodontitis. The prevalence of post treatment apical periodontitis has been reported to be 60% to 80%. Endodontic microsurgery and root resection removes the inaccessible apical ramifications and ensures adequate sealing of apical communication. Magnification has been recommended for better visualization of apical terminus. Various case reports and retrospective studies have reported higher success of apical surgery when magnification devices have been used as an adjunct to periapical surgery (setzer 2010, tsesis 2006, bud 2020). However, there are very few prospective studies and there is heterogeneity in data in terms of type of magnification used and there are very few studies comparing different magnification devices.

To the best of our knowledge no randomized controlled trial has been done on the periapical surgery of maxillary anterior teeth which compares the effect of magnification by microscope versus loupes, hence the aim of this study is to assess the quality of life and success after endodontic surgery using with or without magnification.

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 (Participant)

盲法说明

Sham piezoelectric setup for patients undergoing conventional surgery.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients between age of 18-55 with the diagnosis of persistent symptomatic apical periodontitis in previously treated teeth with radiographic evidence of periapical radiolucency (≥ 5 mm). (Bharathi et al 2021) Tooth with a peri radicular lesion of strictly endodontic origin and unrestorable by nonsurgical retreatment. ASA-1 patients according to the classification of the American Society of Anesthesiologists).

排除标准

  • •Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) Combined endodontic-periodontic lesions Pregnancy

研究组 & 干预措施

Loupes group

Active Comparator

Surgery performed under loupes

干预措施: Surgery under loupes (Procedure)

Loupes group

Active Comparator

Surgery performed under loupes

干预措施: surgery performed under microscope (Procedure)

Microscope group

Experimental

Surgery performed under microscope

干预措施: Surgery under loupes (Procedure)

Microscope group

Experimental

Surgery performed under microscope

干预措施: surgery performed under microscope (Procedure)

结局指标

主要结局

Healing assessment

时间窗: After 6 months and 12 months

2D radiographic healing was assessed by the criteria followed by RUD et al and MOLVEN et al , 3D CBCT healing was assessed by modified PENN'S criteria

Quality of life assessment

时间窗: till 7 days after surgery

To determine the quality of life after endodontic microsurgery with high and low magnification using modified version of sugars et al and OHIP by tsesis et al. assessed by 5-point Likert scale till 1 week.

次要结局

  • Pain assessment(till 7 postoperative days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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