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临床试验/NCT06270784
NCT06270784已完成不适用

Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve

Marmara University2 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2024年1月17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
46
试验地点
2
主要终点
2-point discrimination test on the 7th day after surgery

研究概览

简要总结

The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:

-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?

Participants will:

  • undergo either traditional or orthodontic extraction
  • be monitored for postoperative paresthesia.

Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage.

详细描述

The extraction of an impacted mandibular third molar is one of the most frequently performed procedures by oral and maxillofacial surgeons. The close anatomical relationship between the root of an impacted mandibular third molar and the inferior alveolar nerve may result in inferior alveolar nerve damage. The incidence of inferior alveolar nerve injury during the removal of an impacted mandibular third molar ranges from 0.35% to 8.4%. In addition to radiographic analysis, various surgical techniques, such as coronectomy, have been proposed to reduce the incidence of inferior alveolar nerve injury.

The orthodontic extraction technique is an orthodontically supported surgical approach that reduces the risk of neurological complications that may occur in inferior alveolar nerve and facilitates the surgical removal of impacted mandibular third molars close to the mandibular canal, even if they are associated with cystic lesions.

The purpose of this study is to examine the effect of orthodontic extraction applied to minimize inferior alveolar nerve damage during the extraction of deeply impacted mandibular third molar teeth on postoperative nerve injury. For this purpose, the postoperative paresthesia findings of patients who underwent orthodontic extraction will be compared with those of those who underwent traditional extraction.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of indication for wisdom tooth extraction for reasons such as pericoronitis, pathological formation, orthodontic reasons, caries, etc.
  • Mandibular impacted wisdom teeth close to the inferior alveolar nerve

排除标准

  • Mandibular impacted wisdom tooth not close to inferior alveolar nerve
  • Wisdom tooth whose apexification has not yet been completed
  • Suspicion of a malignant pathological lesion
  • Pathological lesion associated with inferior alveolar nerve
  • Presence of an acute infection

研究组 & 干预措施

Traditional Extraction Group

Active Comparator

干预措施: Traditional Extraction (Procedure)

Orthodontic Extraction Group

Experimental

干预措施: Orthodontic Extraction (Procedure)

结局指标

主要结局

2-point discrimination test on the 7th day after surgery

时间窗: A 2-point discrimination test will be performed before the extraction and 7 days after extraction in both groups.

The primary outcome measure of the study was the assessment of nerve injury. For this purpose, postoperative nerve injury will be recorded by a 2-point discrimination test with the help of a caliper with a 1mm gap.

次要结局

  • Visual Analog Score(VAS)(VAS will be evaluated on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.)
  • 2-point discrimination test on the 14th days and the 1st, 3rd, and 6th months after extraction.(A 2-point discrimation test will be performed on the 14th days and the 1st, 3rd, and 6th months after extraction.)
  • Inferior alveolar nerve recovery(Inferior alveolar nerve recovery will be assessed on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.)

研究者

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

Senem Askin Ekinci

Principal Investigator

Marmara University

研究点 (2)

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