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Completed

NCT Number: NCT04807946

Study on the Risk of Inferior Alveolar Nerve Damage During Lower Third Molar Surgery

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.

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Key information

Conditions

Mandibular Nerve Injury Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Facial Nerve Diseases Facial Neuralgia Mandibular Nerve Injuries Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trauma, Nervous System Trigeminal Nerve Diseases Trigeminal Nerve Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • luxation of the coronal portion of the tooth/root in an ipsilateral or parallel direction with respect to the IAN position and running, in order to minimize nerve compression;
  • post-extraction residual bone cavity inspection using a Zeiss 4x300 magnification optical system to better identify intra-operative nerve exposure.

No material was inserted into the residual cavity, neither by regeneration nor by haemostasis.

After one week, 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lower Third Molar Extraction

Procedure

All surgeries were performed by the same expert surgeon (RP), with the buccal approach using local anesthesia, and included the following maneuvers:

  • luxation of the coronal portion of the tooth/root in an ipsilateral or parallel direction with respect to the IAN position and running, in order to minimize nerve compression;
  • post-extraction residual bone cavity inspection using a Zeiss 4x300 magnification optical system to better identify intra-operative nerve exposure.

No material was inserted into the residual cavity, neither by regeneration nor by haemostasis.

After one week, 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.

Primary outcomes

  1. Assessment of sensitivity alteration after extraction

    Time frame: 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.

  2. Change of Sensitivity after every week for the first month

    Time frame: 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.

  3. Change of Sensitivity after every two week for the second month until resolution

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

A Prospective Observational Study on the Variables Affecting the Risk of Inferior Alveolar Nerve Damage During Lower Third Molar Surgery With Nerve/Root Proximity

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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