A Prospective Observational Study on the Variables Affecting the Risk of Inferior Alveolar Nerve Damage During Lower Third Molar Surgery With Nerve/Root Proximity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 主要终点
- Assessment of sensitivity alteration after extraction
研究概览
简要总结
Objective The present study aimed to evaluate which factors were statistically associated with a greater probability of inferior alveolar nerve (IAN) damage during lower third molar surgery.
Study Design A prospective observational study was performed at the Oral Surgery Unit of the Umberto I Hospital on 92 patients which underwent surgical extraction of a lower third molar, that was radiographically overlapped to the mandibular canal. All surgeries were performed by the same expert surgeon. A principal component analysis and the exact two-tailed Fisher test were used.
详细描述
Exclusion criteria were the following:
- lower third molar buds;
- lack of contiguous second molar;
- wide cyst-like areas or severe osteo-metabolic/tumor pathologies associated with the lower third molar;
- pre-operative neurosensory deficit related to IAN on the side where surgery was to be performed.
Clinical and radiographic data were noted on a special chart, developed in four areas concerning the patient's personal data, pre-operative case evaluation, surgical technique, and post-operative course.
Assessment of surgical difficulty was reached using a modified Pederson's scale by assigning a 1 to 3 score to each of the following variables: tooth inclination (mesioangular/vertical = 1; horizontal = 2; distoangular = 3), depth of impaction (modified Winter classification: A/B = 1; C1 = 2; C 2= 3), Pell & Gregory class (I = 1; II = 2; III = 3), root morphology (fused or slightly divergent = 1; strongly divergent = 2; presence of apical anomalies = 3), proximity to the IAN (none = 1; contiguity = 2; embrication = 3) and maximum mouth opening (> 4 cm = 1; 3-4 cm = 2; < 3 cm = 3). For each extracted third molar, a total score between 6 and 18 was therefore obtained.
All surgeries were performed by the same expert surgeon (RP), with the buccal approach using local anesthesia, and included the following maneuvers:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •orthopantomographic superimposition between the lower third molar and at least the upper half of the mandibular canal, associated or not with the presence of one or more radiographic signs of proximity among those proposed by Rood and Shehab (1990):
- •3-dimensional radiographic examination with a CT software;
- •any type of lower third molar impaction.
排除标准
- •lower third molar buds;
- •lack of contiguous second molar;
- •wide cyst-like areas or severe osteo-metabolic/tumor pathologies associated with the lower third molar;
- •pre-operative neurosensory deficit related to IAN on the side where surgery was to be performed.
结局指标
主要结局
Assessment of sensitivity alteration after extraction
时间窗: After 7 days, at the suture removal, the sensitivity was tested.
sensitivity in the territory of innervation of the inferior alveolar nerve, sensitivity was tested on both sides with the tactile test using a 27-gauge needle tip and, if a difference was found, the patient was followed up once a week for the first month and every two weeks thereafter, until he/she reported to perceive the pin-prick test in the affected side the same way as the healthy side.
Change of Sensitivity after every week for the first month
时间窗: in case of alteration the checks were carried out every weeks up to 30 days
sensitivity in the territory of innervation of the inferior alveolar nerve, sensitivity was tested on both sides with the tactile test using a 27-gauge needle tip and, if a difference was found, the patient was followed up once a week for the first month and every two weeks thereafter, until he/she reported to perceive the pin-prick test in the affected side the same way as the healthy side.
Change of Sensitivity after every two week for the second month until resolution
时间窗: in case of alteration over 30 days we checks every 2 weeks until resolution, up to 365 days.
sensitivity in the territory of innervation of the inferior alveolar nerve, sensitivity was tested on both sides with the tactile test using a 27-gauge needle tip and, if a difference was found, the patient was followed up once a week for the first month and every two weeks thereafter, until he/she reported to perceive the pin-prick test in the affected side the same way as the healthy side.
次要结局
未报告次要终点
研究者
Pippi Roberto
Professor
University of Roma La Sapienza