Localization of Mental Foramen in Relation to Primary Mol... | NCT05663190

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

NCT05663190

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Dec 23, 2022Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Mental Foramen
Cone Beam Computed Tomography

Interventions

mental foramen location

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2022Actual

Primary Completion Date

Aug 15, 2022Actual

Completion Date

Oct 20, 2022Actual

First Submitted Date

Nov 23, 2022

First Submission Date that Met QC Criteria

Dec 21, 2022

First Posted Date

Dec 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2022

Last Update Posted Date

Dec 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

. 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.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mental foramen location	Other	location of mental foramen in relation to primary molars	1

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
maha M azab	Fayoum University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alpha Dent		Al Fayyum			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided