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

NCT04807946 | Completed

• 1 other identifier: 4111
• Study Type: observational
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mandibular Nerve Injury

Outcome Measures

Primary Outcomes (3)

• Assessment of sensitivity alteration after extraction

  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.

  After 7 days, at the suture removal, the sensitivity was tested.

• Change of Sensitivity after every week for the first month

  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.

  in case of alteration the checks were carried out every weeks up to 30 days

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

  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.

  in case of alteration over 30 days we checks every 2 weeks until resolution, up to 365 days.

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Each patient came to the Oral Surgery Unit of the Umberto I Hospital, Department of Odontostomatological and Maxillofacial Sciences, Sapienza University of Rome to extract the lower third molar that present the inclusion criteria. Patients were enrolled only after giving consent to participate in the study. Consent to statistical treatment of clinical and radiographic data was also obtained from all patients.

You may qualify if:

• 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):
• dimensional radiographic examination with a CT software;
• any type of lower third molar impaction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Mandibular Nerve Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 19, 2021
• Study Start: April 1, 2016
• Primary Completion: January 29, 2019
• Study Completion: February 8, 2019
• Last Updated: March 19, 2021

Record last verified: 2021-03