Resection CavityNCT03752554
Assessment of Neurosensory Function Following Segmental Mandibular Resection.
An observational study of Resection Cavity, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Resection Cavity
- What is being tested?
- segmental resection
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2018to 30 Dec 2020
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients with non malignant mandibular lesions
Who may be able to join
- -Age group: from 15 to 60 years old.
- Patients with with non malignant mandibular neoplasms indicated for segmental resection..
Who cannot join
- -Patients with malignant mandibular neoplasms
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Einy Cairo Univeristy
Cairo
ragia mo mounir, professor, 01006600993, ragiamounir@gmail.com
adel h aboelftouh, ass prosf, 01018871899, aabouelfetouh@dentistry.cu.edg.eg
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Resection Cavity
- Being tested
- segmental resection
- Keywords
- segmental mandibular resection-IAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental resectionProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of nerve stimulation
somatosensory evoked potential technique
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start15 Nov 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resection CavityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sherif awad, Cairo University
- Investigators
- ragia mo mounir, professor, Principal investigator, kaser elany cairo univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752554
- Sponsor's protocol ID
- CEBD-CU-2018-11-10
- Status last verified
- Dec 2018
- First submitted
- 17 Nov 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: international publishing
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neurosensory Function Following Segmental Mandibular Resection of Non-malignant Lesions With Inferior Alveolar Nerve Preservation: A Case Series Trial
- ClinicalTrials.gov ID
- NCT03752554
- Acronym / sponsor ID
- CEBD-CU-2018-11-10
- Conditions
- Resection Cavity
- Keywords
- segmental mandibular resection-IAN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 26 Nov 2018 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients with non malignant mandibular lesions
Key inclusion criteria (2 listed)
- -Age group: from 15 to 60 years old.
- Patients with with non malignant mandibular neoplasms indicated for segmental resection..
Key exclusion criteria (1 listed)
- -Patients with malignant mandibular neoplasms
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 |
|---|---|---|
| segmental resectionAll 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 | Procedure or surgery | – |
Primary outcome
measurement of nerve stimulation
Time frame: 3 months
somatosensory evoked potential technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- preservation of inferior alveolar nerveLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. international publishing
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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.
ragia mo mounir, professor principal investigator
kaser elany cairo univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resection Cavity, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahmoud mo shalash, researcher (01006151498, shalash_dentistry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of nerve stimulation (time frame: 3 months). 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 24 Jan 2019.