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临床试验/NCT05667389
NCT05667389尚未招募不适用

Evaluation of the Vascular and Neural Elements Located in the Symphyseal Region Before Implant Surgery: a Retrospective Study of Cone Beam Computed Tomography (CBCT) Scans of the Face Performed on Totally Edentulous Patients in the Odontology Department of the Rothschild Hospital

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Characteristics of the vascular and nervous elements located in the edentulous symphyseal area

研究概览

简要总结

The placement of implants in the symphyseal region is common, especially in the treatment of totally edentulous patients. Some implant surgical procedures may however be responsible for lesions of the vascular and nervous elements in the symphyseal region. The prevention of vascular and nervous accidents during or after implant surgery is based on the identification of vascular and nervous elements.

Although the anatomy of the symphyseal region is rather well described in the literature, the data concerning totally edentulous patients remains fragmented. These suggest that tooth avulsion and bone resorption have an influence on the anatomy of the mandibular region, and of the vascular and nervous elements traveling in the anterior mandibular part. These modifications would be responsible for individual anatomical variations.

In order to test this hypothesis, the investigator wish to evaluate the anatomical characteristics of the vascular and nervous elements located in the symphyseal region, retrospectively, of a totally edentulous population for which the anatomy was documented in a three-dimensional way from 2013 to 2021 before the placement of dental implants.

详细描述

The placement of dental implants in the anterior mandibular region is considered a rather safe and predictable procedure because this region has a limited number of neurovascular elements, a relatively extensive vestibular and lingual cortical bone structure, and dense trabecular bone providing high primary stability and excellent implant survival. However, this anatomical region is not free of risks, some of which are associated with potentially fatal complications (cases of death following a hemorrhagic accident have for example been described). Many clinical cases thus illustrate complications of implant surgery in the symphyseal region such as nerve damage, bone fractures, infections, and bleeding during or after the placement of the dental implant.

Implant surgery can indeed generate nerve damage according to different mechanisms by nerve compression or dilaceration by direct contact of the drill and/or the implant with the nerve compression linked to peri-implant edema or compressed bone debris at the bottom of the drill site.irritation by release of inflammatory mediators from adjacent inflamed or necrotic bone or thermal injury (heating during implant drilling). Nerve injury is clinically manifested by symptoms of varying stage and severity depending on the severity of the injury caused to the nerve. Clinically, nerve damage to the sensory afferents of the NAI can generate sensory dysfunction such as paresthesia (abnormal sensitivity), hypoesthesia (decreased sensitivity), hyperesthesia (increased sensitivity), dysesthesia (unpleasant sensitivity that may result in pain ) or even anesthesia (complete loss of sensitivity) localized to the territory of innervation of the injured nerve. From the epidemiological point of view, the frequency of such complications would be estimated between 0 and 24% for transient lesions and between 0 and 11% for irreversible lesions. Two retrospective studies carried out with more than 1300 patients with iatrogenic lesions of peripheral trigeminal afferents observed that 13% presented with pain following implant surgery.Implant surgery would thus be the second cause of NAI lesions (18%), after wisdom tooth extraction .

In implantology, vascular effraction is most often observed after perforation of the lingual cortex of the symphyseal or posterior regions , the drill causing the tearing of the underlying vascular structures. A fracture of the internal cortex during implant surgical procedures thus increases the risk of bleeding. At the level of the symphyseal region, the lesion of the sublingual artery can for example be responsible for abundant bleeding or intraoperative hemorrhage, and/or hematoma of the floor of the mouth per or postoperative , with a risk of obstruction of the upper digestive airways. From a clinical point of view, it seems very complicated to be able to establish with certainty the origin of bleeding from the floor of the mouth and only endovascular angiography can determine its origin, which complicates the management of this type of complication.

Although the anatomy of the symphyseal region is rather well described in the literature, the data concerning totally edentulous patients remains fragmented. These suggest that the avulsion of the anterior teeth and the bone resorption have an influence on the anatomy of the mandibular region, and of the vascular and nervous elements traveling in the anterior mandibular part. These modifications would be responsible for individual anatomical variations which could constitute unfavorable anatomical conditions with damage to vascular and/or nervous elements during implant surgical procedures.

In order to test this hypothesis, the investigator wish to evaluate the anatomical characteristics of the vascular and nervous elements located in the symphyseal region within a completely edentulous population for which the anatomy has been documented in a three-dimensional way before the placement of dental implants. A better knowledge of the anatomy and anatomical variations affecting the edentulous symphyseal region would allow identification of patients for whom there is a proximity between the implantation sites and the vascular and nervous elements in the edentulous symphyseal zone.

研究设计

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

入排标准

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

入选标准

  • Adult patients aged > 18 years old, totally edentulous, that have benefited from a CBCT examination in the odontology department with a view to implantation in the symphyseal region from 2013 to 2021
  • Not opposed to the use of their data

排除标准

  • Non-French speaking person

结局指标

主要结局

Characteristics of the vascular and nervous elements located in the edentulous symphyseal area

时间窗: Before implant placement (one day)

Number and localisation of foramina location

次要结局

  • Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : diameter(Before implant placement (one day))
  • Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : mesio-distal dimension(Before implant placement (one day))
  • Anatomical characteristics of the edentulous symphyseal area.(Before implant placement (one day))
  • Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : diameter of the opening(Before implant placement (one day))
  • Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : vestibular and lingual position(Before implant placement (one day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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