Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04807946 |
Other study ID # |
4111 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 1, 2016 |
Est. completion date |
February 8, 2019 |
Study information
Verified date |
March 2021 |
Source |
University of Roma La Sapienza |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
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.