Mandibular Nerve InjuryNCT04807946
Study on the Risk of Inferior Alveolar Nerve Damage During Lower Third Molar Surgery
An observational study of Mandibular Nerve Injury, run by University of Roma La Sapienza.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mandibular Nerve Injury
- What is being tested?
- lower third molar extraction
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 8 Feb 2019
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Mandibular Nerve Injury
- Being tested
- lower third molar extraction
- Medical subject headings
- Mandibular Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower third molar extractionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: in case of alteration over 30 days we checks every 2 weeks until resolution, up to 365 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Apr 2016
- Primary completion29 Jan 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Nerve InjuryStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pippi Roberto, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807946
- Sponsor's protocol ID
- 4111
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04807946
- Acronym / sponsor ID
- 4111
- Conditions
- Mandibular Nerve Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lower third molar extractionAll 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. | Procedure or surgery | – |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Nerve Injury, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of sensitivity alteration after extraction (time frame: After 7 days, at the suture removal, the sensitivity was tested.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.