Localization of Mental Foramen in Relation to Primary Molars A Cone Beam Computed Tomography Study

. The aim of this study was to determine the location of mental foramen in relation to the lower primary molars using Cone Beam Computed Tomography. And develop simple guidelines for the injection of mental block anaesthesia for children.

Study Overview

• Status: Completed
• Conditions: Cone Beam Computed Tomography; Mental Foramen
• Intervention / Treatment: Other: mental foramen location

Detailed Description

Cone Beam Computed Tomographies in a private radiology centre will be screened, Cone Beam Computed Tomography images of less than 10 years old, boys or girls were included in the study. Included Cone Beam Computed Tomography images should have either or both sides of the lower arch in the field of view, with the lower first and second primary molars with no or minimal root resorption. Images with pathologies, fractures, malformations, or abnormal location of teeth that would affect the anatomy or location of mental foramen were excluded from the study.

The vertical diameter of mental foramen was measured on the cross-sectional Cone Beam Computed Tomography images, while the horizontal diameter was measured on the axial scans. The ratio between horizontal and vertical diameters (H:V) was calculated to determine the form of mental foramen

Outcomes

1: vertical and horizontal location of mental foramen in relation to 1ry molars 2. subgroup analysis for the 1st outcome according to age, (< 6 years) vs (> 6 yrs) 3. Mental foramen form according to the Horizontal/Vertical ratio 4. If there is any relation between (location, form, vertical or horizontal dimension of mental foramen) and (Side or Gender)

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Alpha Dent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cone beam computed tomography lower arch images for less than 10-year-old children

Description

Inclusion Criteria:

Included cone beam computed tomography images should have either or both sides of the lower arch in the field of view, with the lower first and second primary molars with no or minimal root resorption.

Exclusion Criteria:

Images with pathologies, fractures, malformations, or abnormal location of teeth that would affect the anatomy or location of mental foramen were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Less than 10-year-old, with cone beam computed tomography imagess with the mental foramen included in field of vision	Other: mental foramen location; location of mental foramen in relation to primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
horizontal location of mental foramen	the location of mental foramen horizontally in relations to the primary molars (using a a modification of Tebo and Telford classification )	Day 1
vertical location of mental foramen	the location of mental foramen vertically in relation to the apices of the primary molars (above/at the same level/below) the apices	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dimension and form of mental foramen	ratio between horizontal and vertical diameter of the mental foramen	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
relation to age	is there is a relation between location of mental foramen and age of a child	Day 1

Collaborators and Investigators

• Sponsor: Fayoum University
• Investigators: Principal Investigator: maha M azab, Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Mental foramen in children

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