Mandibular NerveNCT04465617
Assessment of the Anterior Loop of the IAN in a Sample of Egyptian Population Using CBCT
An observational study of Mandibular Nerve, run by Cairo University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Nerve
- How many people
- 192 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult Egyptian population including males \& females
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Abdelrahman Zohny contact
Egypt1 site, 1 recruiting
- Recruiting
Orascan
Cairo, Maadi, 11728
Orascan Oral & Maxillofacial Imaging Centre, +20223780756, Info@orascan.org
Abdelrahman Zohny, 01222376888
About this study
Official title: 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
Read the 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.
- Conditions
- Mandibular Nerve
- Keywords
- Presence of the anterior loop of the mental nerve (branching from the inferior alveolar nerve) will be recorded & its length will be measured
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the anterior loop
it will be measured using CBCT axial cuts (Ondemand 3D software)
Measured: 1 month
Secondary outcomes (2)
length of the anterior loop
Built in measuring tools (axial cuts) in Ondemand 3D software "MPR* module"
Measured: 1 month
Mesial extension of the anterior loop
Cross-sectional cuts on Ondemand 3D software "DVR** module"
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Sep 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular NerveStudies 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
- Retrospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Hossam Kandil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465617
- Sponsor's protocol ID
- ORAD 7.1.1
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2020
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Anterior Loop of the Inferior Alveolar Nerve in a Sample of Egyptian Population Using CBCT: An Observational Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04465617
- Acronym / sponsor ID
- ORAD 7.1.1
- Conditions
- Mandibular Nerve
- Keywords
- Presence of the anterior loop of the mental nerve (branching from the inferior alveolar nerve) will be recorded & its length will be measured
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Jul 2020 (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.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult Egyptian population including males \& females
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of the anterior loop
Time frame: 1 month
it will be measured using CBCT axial cuts (Ondemand 3D software)
2 secondary outcomes
length of the anterior loop
Time frame: 1 month
Mesial extension of the anterior loop
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Surgeons' Prediction of Dental Surgery Complications and the Influence of Patient Characteristics: Development of an AI Model
Postoperative Infections, Mandibular Nerve Injuries
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.
Abdelrahman Zohny contact
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 Mandibular Nerve, 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 2 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 5 Nov 2021. 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 ORASCAN Oral & Maxillofacial Imaging Centre (+2 0223780756, Info@orascan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the anterior loop (time frame: 1 month). 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 5 Nov 2021.