Assessment of Neurosensory Function Following Segmental Mandibular Resection.

Resection Cavity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03752554
• Other study ID #: CEBD-CU-2018-11-10
• Status: Recruiting
• Start date: November 15, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: mahmoud mo shalash, researcher
• Phone: 01006151498
• Email: shalash_dentistry[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Resection Cavity

Intervention

Procedure:
• segmental resection
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

Locations

Country	Name	City	State
Egypt	Kasr Al Einy Cairo Univeristy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of nerve stimulation	somatosensory evoked potential technique	3 months

External Links

•   preservation of inferior alveolar nerve