Assessment of Neurosensory Function Following Segmental Mandibular Resection.

Assessment of Neurosensory Function Following Segmental Mandibular Resection of Non-malignant Lesions With Inferior Alveolar Nerve Preservation: A Case Series Trial

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

Study Overview

• Status: Unknown
• Conditions: Resection Cavity
• Intervention / Treatment: Procedure: segmental resection

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: mahmoud mo shalash, researcher; Phone Number: 01006151498; Email: shalash_dentistry@gmail.com
• Study Contact Backup: Name: adel h aboelftoh, ass prof; Phone Number: 01018871899; Email: aabouelfetouh@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Kasr Al Einy Cairo Univeristy
    • Contact: ragia mo mounir, professor; Phone Number: 01006600993; Email: ragiamounir@gmail.com
    • Contact: adel h aboelftouh, ass prosf; Phone Number: 01018871899; Email: aabouelfetouh@dentistry.cu.edg.eg
    • Principal Investigator: ragia mounir, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with non malignant mandibular lesions

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of nerve stimulation	somatosensory evoked potential technique	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: ragia mo mounir, professor, kaser elany cairo univeristy

Publications and helpful links

Helpful Links

• preservation of inferior alveolar nerve

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: November 17, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: segmental mandibular resection-IAN
• Other Study ID Numbers: CEBD-CU-2018-11-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: international publishing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No