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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

  • Egypt
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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