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临床试验/NCT02519426
NCT02519426Unknown不适用

Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial

Lithuanian University of Health Sciences2 个研究点 分布在 2 个国家目标入组 110 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
Duration of the mandibular third molar surgery

研究概览

简要总结

The study evaluates and validates a new classification proposed by Juodzbalys and Daugela in 2013 predicting the complexity of impacted mandibular third molars surgical extraction, comparing it with other two, scientifically approved (Pell and Gregory, Winter) classifications.

详细描述

The extraction of mandibular impacted wisdom teeth is the most widespread surgical procedure performed in oral surgery. There are many situations indicating the extraction of those teeth as well as risks and protective factors that may contraindicate it. A reliable classification predicting the complexity of the surgical procedure and the related risk of complications would greatly help the surgeon in the diagnostic phase.

The aim of the study is to evaluate if the classification proposed by Juodzbalys and Daugela in 2013 could be effective in predicting the complexity of impacted mandibular third molars surgical extraction, and to compare its effectiveness with commonly used Pell and Gregory, Winter classifications.

A blind expert surgeon will assess postoperatively all CBCTs (Cone beam computed tomographies) and OPGs (orthopantomographs) not older than 12 months, and will assign the score for each extracted tooth for the three classification (Juodzbalys and Daugela - Pell and Gregory - Winter). Duration of the surgical procedure, assessment of the surgical technique and of intra- and post-operative complications will be considered as the main parameters to evaluate surgical difficulty. VAS (Visual Analogue Scale) pain score and NSAID (Nonsteroidal anti-inflammatory drug) pills count taken by each patient of the 7 days postoperative period will be also evaluated.

Statistical unit analyzed will be the single tooth. It should be noted that if a single patient has a bilateral impacted tooth to be extracted it will be randomly selected only one to be analyzed. Patients will be divided into two groups according to Juodzbalys and Daugela classification score (x<9≤y), two groups according to each predicted extraction difficulty to Pell Gregory (x<Class 2B≤y) and Winter (x<Horizontal impaction≤y) classifications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients with an age comprised between 16 to 90 years
  • Healthy patients ( ASA (American Society of Anesthesiologists) Physical status index ≤ 2)
  • CBCT and/or OPG performed not before than 12 months before surgery
  • Complete roots formation of 38 or 48 at CBCT and/or OPG examination
  • Signed informed consent

排除标准

  • Smoking > 10 cigarettes per day
  • Presence of any neoplastic lesion (benign or malignant), clinically or radiologically evaluable, at the site or close to the impacted tooth
  • Presence of any radiolucent lesion >1 cm at impacted tooth level

结局指标

主要结局

Duration of the mandibular third molar surgery

时间窗: Up to 2 hours

Duration of the surgical procedure is counted from the beginning of surgical manipulations to complete removal of mandibular wisdom tooth and wound closure if applicable.

次要结局

  • Composite assessment of the surgical technique and of intra - and post-operative complications(7 days)
  • Pain and Discomfort assessment with VAS scale(7 days)
  • NSAID assumption(7 days)

研究者

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

Povilas Daugela

Assistant

Lithuanian University of Health Sciences

研究点 (2)

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