NCT04465617

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 5, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

June 28, 2020

Last Update Submit

November 4, 2021

Conditions

Keywords

Presence of the anterior loop of the mental nerve (branching from the inferior alveolar nerve) will be recorded & its length will be measured

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the anterior loop

    it will be measured using CBCT axial cuts (Ondemand 3D software)

    1 month

Secondary Outcomes (2)

  • length of the anterior loop

    1 month

  • Mesial extension of the anterior loop

    1 month

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Egyptian population including males \& females

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orascan

Cairo, Maadi, 11728, Egypt

RECRUITING

Central Study Contacts

ORASCAN Oral & Maxillofacial Imaging Centre

CONTACT

Abdelrahman Zohny

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Oral & Maxillofacial Radiology, Faculty of Dentistry

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 10, 2020

Study Start

September 1, 2021

Primary Completion

April 1, 2022

Study Completion

June 1, 2022

Last Updated

November 5, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations