Mental ForamenNCT05663190
Localization of Mental Foramen in Relation to Primary Molars A Cone Beam Computed Tomography Study
An observational study of Mental Foramen and Cone Beam Computed Tomography, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Mental Foramen, Cone Beam Computed Tomography
- What is being tested?
- mental foramen location
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2022to 20 Oct 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 4 to 10 years
- All sexes
- Child
Study population: Cone beam computed tomography lower arch images for less than 10-year-old children
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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)
- Conditions
- Mental Foramen, Cone Beam Computed Tomography
- Being tested
- mental foramen location
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental foramen locationOther
location of mental foramen in relation to primary molars
| Study group | Role | What they receive |
|---|---|---|
| 1 | Less than 10-year-old, with cone beam computed tomography imagess with the mental foramen included in field of vision Receives: Other: mental foramen location |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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
Measured: Day 1
Secondary outcomes (1)
dimension and form of mental foramen
ratio between horizontal and vertical diameter of the mental foramen
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start7 Apr 2022
- Primary completion15 Aug 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental ForamenStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Moussa Azab, Fayoum University
- Investigators
- maha M azab, Principal investigator, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663190
- Sponsor's protocol ID
- Mental foramen in children
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 23 Dec 2022
- 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 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of Mental Foramen in Relation to Primary Molars A Cone Beam Computed Tomography Study
- ClinicalTrials.gov ID
- NCT05663190
- Acronym / sponsor ID
- Mental foramen in children
- Conditions
- Mental Foramen, Cone Beam Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 23 Dec 2022 (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.
. 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)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: mental foramen locationLess than 10-year-old, with cone beam computed tomography imagess with the mental foramen included in field of vision |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- Cone beam computed tomography lower arch images for less than 10-year-old children
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mental foramen locationlocation of mental foramen in relation to primary molars | Other | 1 |
Primary outcome
horizontal location of mental foramen
Time frame: Day 1
the location of mental foramen horizontally in relations to the primary molars (using a a modification of Tebo and Telford classification )
vertical location of mental foramen
Time frame: Day 1
the location of mental foramen vertically in relation to the apices of the primary molars (above/at the same level/below) the apices
1 secondary outcome
dimension and form of mental foramen
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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.
maha M azab principal investigator
Fayoum University
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 Mental Foramen and Cone Beam Computed Tomography, run by Fayoum 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
horizontal location of mental foramen (time frame: Day 1). The study lists 2 primary outcomes in all. 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 23 Dec 2022.