Assessment of Neurosensory Function Following Segmental Mandibular Resection.

NCT03752554 | Unknown

• 1 other identifier: CEBD-CU-2018-11-10
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Resection Cavity

Keywords

segmental mandibular resection-IAN

Outcome Measures

Primary Outcomes (1)

• measurement of nerve stimulation

  somatosensory evoked potential technique

  3 months

Interventions

segmental resection PROCEDURE

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

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with non malignant mandibular lesions

You may qualify if:

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

You may not qualify if:

• Patients with malignant mandibular neoplasms

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Einy Cairo Univeristy

Cairo, Egypt

RECRUITING

Related Links

• preservation of inferior alveolar nerve

MeSH Terms

Interventions

Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• ragia mo mounir, professor

  kaser elany cairo univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mahmoud mo shalash, researcher

CONTACT

01006151498; shalash_dentistry@gmail.com

adel h aboelftoh, ass prof

CONTACT

01018871899; aabouelfetouh@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant researcher in national research centre

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 26, 2018
• Study Start: November 15, 2018
• Primary Completion: January 1, 2020
• Study Completion: December 30, 2020
• Last Updated: January 24, 2019

Record last verified: 2018-12

Locations

EG (1)