Clinical trial NCT03752554: Assessment of Neurosensory Function Following Segmental Mandibular Resection.
Official title: Assessment of Neurosensory Function Following Segmental Mandibular Resection of Non-malignant Lesions With Inferior Alveolar Nerve Preservation: A Case Series Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Resection Cavity
Keywords: segmental mandibular resection-IAN
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non malignant mandibular lesions

Brief summary: This study wInclusion criteria for this study will be as follows:

* Age group: from 15 to 60 years old.
* Patients with with non malignant mandibular neoplasms indicated for segmental resection.

Exclusion criteria:

* Patients with malignant mandibular neoplasms.

All cases will undergo surgery under general anesthesia. The mandibular lesion will be segmentally resected. The cuts will be performed with the aid of the prefabricated digital template. The neurovascular bundle will be separated and protected. Then reconstruction will be performed.

Postoperative patient evaluation:

Neurosensory examination:

Assessment of the inferior alveolar nerve function will be performed preoperatively, 2 and 12 weeks postoperatively through Trigeminal somatosensory evoked potential technique. Six months postoperatively by CBCT for assessment of recurrence

Detailed description: This study will include 10 patients complaining from non malignant mandibular lesions. nopatients will be selected from the outpatient clinic of the Oral \& Maxillofacial Surgery department, faculty of Dental Medicine Cairo University.

All the procedures will be explained for all patients before undergoing operation and informed consent process will be taken, this study will be displayed to the research ethics committee to obtain approval.

Inclusion criteria for this study will be as follows:

* Age group: from 15 to 60 years old.
* Patients with with non malignant mandibular neoplasms indicated for segmental resection.

Exclusion criteria:

* Patients with malignant mandibular neoplasms. 1- Pre-operative phase

Patients will be subjected to:

Case history including personal data, medical, a-surgical and family history b-Clinical examination c.Radiographic examination using orthopantogram, and computed tomography (CT) Preoperative anesthesia assessment for fitness for general anesthesia.d Treatment planning and fabrication of the digital template.e 2 -Operative phase All cases will undergo surgery under general anesthesia. The mandibular lesion will be segmentally resected. The cuts will be performed with the aid of the prefabricated digital template. The neurovascular bundle will be separated and protected. Then reconstruction will be performed.

3-Postoperative care:

Postsurgical instructions and follow up:

Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics.

Postoperative patient evaluation:

Neurosensory examination:

Assessment of the inferior alveolar nerve function will be performed preoperatively, 2 and 12 weeks postoperatively through Trigeminal somatosensory evoked potential technique. Six months postoperatively by CBCT for assessment of recurrence.

Statistical analysis:

Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc. Chicago). The data will be compared using paired t-test.

Eligibility criteria: Inclusion Criteria:

* -Age group: from 15 to 60 years old.
* Patients with with non malignant mandibular neoplasms indicated for segmental resection..

Exclusion Criteria:

* -Patients with malignant mandibular neoplasms

Primary outcomes:
measure: measurement of nerve stimulation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Einy Cairo Univeristy
Study officials:
affiliation: kaser elany cairo univeristy
name: ragia mo mounir, professor
role: PRINCIPAL_INVESTIGATOR
References: