Mandibular FracturesIndicesNCT03714035
Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages
An observational study of Mandibular Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
this study aims to correlate mandibular indices and different ages in a sample of Egyptian population. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Mandibular Fractures
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2018to Oct 2019
- 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 10 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: a sample of egyptian population
Who may be able to join
- Egyptian individuals with different ages starting from 10 - 70 years.
- Females and males of the mentioned ages.
Who cannot join
- Individuals younger than 10 and older than 70 years old.
- Presence of a large pathological lesions in the mandible at the areas intended for measurements.
- Patients of severely resorbed mandibular bone.
- Patients with any bony deformity at the inferior border of the mandible.
- Patients with fracture at the areas to be examined.
- Patients with evident radiographic asymmetry.
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- Patients with evident radiographic abnormality suggestive of systemic disease predisposing to osteoporosis.
- Patients with current postoperative surgical defect healing at the areas intended for measurements.
- Patients with mandibular reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages Using Cone Beam Computed Tomography: A Cross Sectional Study
this study aims to correlate mandibular indices and different ages in a sample of Egyptian population.
Read the detailed description
this study is an observational cross sectional study to correlate the mandibular radiomorphometric indices with age in sample of egyptian population using CBCT scans at faculty of dentistry cairo university
- Conditions
- Mandibular Fractures
- Being tested
- no intervention
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
panoramic mandibular index
ratio between the thickness of the mandible at the mental foramen area and the distance measured from the inferior border of the mental foramen to the inferior border of the mandible. The value of 0.3 will be considered as normal value while the lower value indicate abnormal inferior border thickness
Measured: 2018-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start30 Oct 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Sayed Mansy, Cairo University
- Investigators
- Dentistry Cairo, Univeristy, Study chair, Ethical committee faculty if dentustry cairo unveristry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714035
- Sponsor's protocol ID
- Hphd
- Other IDs
- FDCU
- Acronym
- Indices
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages Using Cone Beam Computed Tomography: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03714035
- Acronym / sponsor ID
- Indices / Hphd
- Conditions
- Mandibular Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 22 Oct 2018 (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.
this study aims to correlate mandibular indices and different ages in a sample of Egyptian population.
Detailed description
this study is an observational cross sectional study to correlate the mandibular radiomorphometric indices with age in sample of egyptian population using CBCT scans at faculty of dentistry cairo university
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- a sample of egyptian population
Key inclusion criteria (2 listed)
- Egyptian individuals with different ages starting from 10 - 70 years.
- Females and males of the mentioned ages.
Key exclusion criteria (9 listed)
- Individuals younger than 10 and older than 70 years old.
- Presence of a large pathological lesions in the mandible at the areas intended for measurements.
- Patients of severely resorbed mandibular bone.
- Patients with any bony deformity at the inferior border of the mandible.
- Patients with fracture at the areas to be examined.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
panoramic mandibular index
Time frame: 2018-2020
ratio between the thickness of the mandible at the mental foramen area and the distance measured from the inferior border of the mental foramen to the inferior border of the mandible. The value of 0.3 will be considered as normal value while the lower value indicate abnormal inferior border thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Dentistry Cairo, Univeristy study chair
Ethical committee faculty if dentustry cairo unveristry
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 Mandibular Fractures, run by Cairo 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hana mansy, PHD (01003266948, hana.manssy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
panoramic mandibular index (time frame: 2018-2020). 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 22 Oct 2018.