- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465617
Assessment of the Anterior Loop of the IAN in a Sample of Egyptian Population Using CBCT
November 4, 2021 updated by: Professor Hossam Kandil, Cairo University
Assessment of the Anterior Loop of the Inferior Alveolar Nerve in a Sample of Egyptian Population Using CBCT: An Observational Cross-Sectional Study
in this study the prevalence & length of the anterior loop of the inferior alveolar nerve will be calculated and measured on retrospective CBCT patient's scans
Study Overview
Status
Recruiting
Conditions
Detailed Description
The proper knowledge of anatomical structures and their precise position is of a paramount importance for different dental specialties.
The inferior alveolar nerve (IAN) canal is one of the most important anatomical landmarks in the mandible Shaban et al., 2017.
By definition the inferior alveolar nerve (IAN) is a terminal division of the mandibular branch of the trigeminal nerve, it is confined within the mandibular canal and innervates all the mandibular teeth.
The IAN initiates from the mandibular foramen and goes obliquely downward and forward in the ramus, and then horizontally within the body of the mandible.
The IAN gives off the mental nerve, which exits the mandible through the mental foramen, supplying sensory branches to the chin, lower lip, mucous membranes and the gingiva; from the midline to about the second premolar region.
It then continues its path anteriorly and turn into the mandibular incisive nerve, which innervates the mandibular canines and incisors Siddiqui et al. 2018.
Before leaving the mental foramen and branching into the incisive nerve, the IAN may continue anteriorly and form an anterior loop (Al).
This anterior loop is the part where the IAN directs mesially and occlusally before reversing direction and coursing distally towards the mental foramen Ragu et al., 2019.
During implant planning and other surgical procedures knowing the presence of the anterior loop and its length is very crucial to avoid its injury.
Specially concerning implantology where the location of the mental foramen and anterior loop determines the most distal point for implant placement in the interforaminal area; in order to avoid any injury resulting in sensory disturbances in this area Panjnoush et al., 2016 Recently, several studies have been published discussing the prevalence and length measurement of the anterior loop in many populations.
However, no published researches were done on the Egyptian population.
Therefore, this study is designed to assess the presence of the anterior loop and its length in a sample of Egyptian population using CBCT.
Study Type
Observational
Enrollment (Anticipated)
192
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ORASCAN Oral & Maxillofacial Imaging Centre
- Phone Number: +2 0223780756
- Email: Info@orascan.org
Study Contact Backup
- Name: Abdelrahman Zohny
- Phone Number: 01222376888
Study Locations
-
-
Maadi
-
Cairo, Maadi, Egypt, 11728
- Recruiting
- Orascan
-
Contact:
- Abdelrahman Zohny
- Phone Number: 01222376888
-
Contact:
- Orascan Oral & Maxillofacial Imaging Centre
- Phone Number: +20223780756
- Email: Info@orascan.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult Egyptian population including males & females
Description
Inclusion Criteria:
- CBCT scans of adult Egyptian patients, males and females.
- CBCT scans with unilateral or bilateral anterior mandibles; with minimum 2 mm length distal to the mental foramen
Exclusion Criteria:
- CBCT images of poor quality or artifacts interfering with the assessment of the anterior loop of IAN.
- Scans showing any pathosis in the interforaminal area (tumor or impaction).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of the anterior loop
Time Frame: 1 month
|
it will be measured using CBCT axial cuts (Ondemand 3D software)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length of the anterior loop
Time Frame: 1 month
|
Built in measuring tools (axial cuts) in Ondemand 3D software "MPR* module"
|
1 month
|
Mesial extension of the anterior loop
Time Frame: 1 month
|
Cross-sectional cuts on Ondemand 3D software "DVR** module"
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Anticipated)
April 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
June 28, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
November 5, 2021
Last Update Submitted That Met QC Criteria
November 4, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ORAD 7.1.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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