NCT05663190

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

November 23, 2022

Last Update Submit

December 21, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • dimension and form of mental foramen

    Day 1

Other Outcomes (1)

  • relation to age

    Day 1

Study Arms (1)

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

location of mental foramen in relation to primary molars

1

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alpha Dent

Al Fayyum, Egypt

Location

Study Officials

  • maha M azab

    Fayoum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 23, 2022

Study Start

April 7, 2022

Primary Completion

August 15, 2022

Study Completion

October 20, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations