Mandibular DimensionsNCT04973241
Mandibular Dimensions as a Predictor of Age and Sex in a Sample of Upper Egypt Population by Using Panoramic Images and Cone Beam Computed Tomography
An observational study of Mandibular Dimensions, run by Assiut University.
Trial summary
Growth changes occur from the intrauterine life to senility, hard tissues like bones and teeth undergo changes with growth, a change in shape and/or fusion of ossification centers, the stability of these changes facilitate ease in estimation of age from hard tissue samples ( Bhalaji ,2006;Reddy,2006; Mohite et… Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Dimensions
- What is being tested?
- OPG & CBCT
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: persons aged between 15 and 40 years.
Who may be able to join
- 1. Panoramic radiographs and cone beam computed tomography of patients aged15-40 years.
- 2. Only patients with a documented date of birth.
Who cannot join
- 1. Asymmetry in OPG and CBCT images, unreadable ,unclear ,poor quality, gross pathology and magnification.
- 2. Panoramic radiographs with positioning errors which could cause distortions in the dimensions.
- 3. Hereditary facial asymmetries. 4. Images of completely edentulous patients. 5. Surgical intervention, patients with orthognathic surgeries. 6. Presence of pathologies such as fractures, impacted teeth, missing teeth, cleft lip or palate, cysts, tumors, osteomyelitis,severe osteoporosis in the mandible, periodontal lesion, and congenital craniofacial abnormalities, in the lower jaw, resorption in the mandibular arch that could affect the interpretation of radiographic image, 7. History of head trauma
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mandibular Dimensions as a Predictor of Age and Sex in a Sample of Upper Egypt Population
Growth changes occur from the intrauterine life to senility, hard tissues like bones and teeth undergo changes with growth, a change in shape and/or fusion of ossification centers, the stability of these changes facilitate ease in estimation of age from hard tissue samples ( Bhalaji ,2006;Reddy,2006; Mohite et al.,2011).
Mandibles were used for the study for two simple causes: First, there appears to be a lack of standards utilizing this element and second, this bone is often recovered mostly intact (Franklin et al.,2008) The mandible is considered the most durable facial bone ;is due to the presence of a dense layer of compact bone and therefore remains well conserved than many other bones and the only movable bone of the skull available for gender identification; is due to the morphological characteristics of mandible, and radiology plays an important role in it. It is composed of two hemi mandibles united at the midline by a vertical symphysis. Each one of them is composed of a horizontal body with a posterior vertical extension termed the ramus(ndira et al.,2012 ).
Read more
Mandibular canines are found to exhibit the highest sexual dimorphism.The mean age of eruption of mandibular canines is 10.87 years, and they are the last teeth to be extracted with respect to age; so, they can be considered as the key teeth for personal identification (Khangura et al.,2011; Padmavati et al.,2011; Yuwanati et al.,2012).
Measurements of the mandibular ramus tend to show higher sexual dimorphism, and variations between the sexes are mostly more marked in the mandibular ramus than in the mandibular body (Humphrey et al.,1999).
Gonial angle is commonly used to determine the rotation of the mandible and to identify growth pattern, it is a common parameter used to describe orthodontic extractions or surgical treatments(Kitai et al.,2013).
Several studies focused on the comparison between CBCT (Cone Beam Computed Tomography) and OPG (Orthopantomograph) for visualization of bone and teeth (Dalessandri et al.,2012 ;Savoldi et al.,2015).
OPG is a very popular technique ,the most available and commonly used extra-oral radiography, its lower cost ,wide area coverage ,ease of preparation have made it an excellent choice for routine examination of many structures thus useful for research purpose does not involve the patient any additional exposure or cost(Ghosh et al.,2009 ;Sairam et al.,2016).
The CBCT imaging device can obtain undistorted three-dimensional (3D) images of good quality with a low radiation dose (Yamamoto et al.,2003).
- Conditions
- Mandibular Dimensions
- Being tested
- OPG & CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPG & CBCTRadiation
panoramic images , cone beam computed tomography
| Study group | Role | What they receive |
|---|---|---|
| OPG | Not described Receives: Radiation: OPG & CBCT | |
| CBCT | Not described Receives: Radiation: OPG & CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of OPG & CBCT
- Comparison of the accuracy in identification of age and sex between using digital orthopantomographs and cone beam computed tomography
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular DimensionsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMM Kotb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973241
- Sponsor's protocol ID
- OPG&CBCT for mandible measures
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Dimensions as a Predictor of Age and Sex in a Sample of Upper Egypt Population
- ClinicalTrials.gov ID
- NCT04973241
- Acronym / sponsor ID
- OPG&CBCT for mandible measures
- Conditions
- Mandibular Dimensions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Jul 2021 (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.
Growth changes occur from the intrauterine life to senility, hard tissues like bones and teeth undergo changes with growth, a change in shape and/or fusion of ossification centers, the stability of these changes facilitate ease in estimation of age from hard tissue samples ( Bhalaji ,2006;Reddy,2006; Mohite et al.,2011).
Mandibles were used for the study for two simple causes: First, there appears to be a lack of standards utilizing this element and second, this bone is often recovered mostly intact (Franklin et al.,2008) The mandible is considered the most durable facial bone ;is due to the presence of a dense layer of compact bone and therefore remains well conserved than many other bones and the only movable bone of the skull available for gender identification; is due to the morphological characteristics of mandible, and radiology plays an important role in it. It is composed of two hemi mandibles united at the midline by a vertical symphysis. Each one of them is composed of a horizontal body with a posterior vertical extension termed the ramus(ndira et al.,2012 ).
Mandibular canines are found to exhibit the highest sexual dimorphism.The mean age of eruption of mandibular canines is 10.87 years, and they are the last teeth to be extracted with respect to age; so, they can be considered as the key teeth for personal identification (Khangura et al.,2011; Padmavati et al.,2011; Yuwanati et al.,2012).
Measurements of the mandibular ramus tend to show higher sexual dimorphism, and variations between the sexes are mostly more marked in the mandibular ramus than in the mandibular body (Humphrey et al.,1999).
Gonial angle is commonly used to determine the rotation of the mandible and to identify growth pattern, it is a common parameter used to describe orthodontic extractions or surgical treatments(Kitai et al.,2013).
Several studies focused on the comparison between CBCT (Cone Beam Computed Tomography) and OPG (Orthopantomograph) for visualization of bone and teeth (Dalessandri et al.,2012 ;Savoldi et al.,2015).
OPG is a very popular technique ,the most available and commonly used extra-oral radiography, its lower cost ,wide area coverage ,ease of preparation have made it an excellent choice for routine examination of many structures thus useful for research purpose does not involve the patient any additional exposure or cost(Ghosh et al.,2009 ;Sairam et al.,2016).
The CBCT imaging device can obtain undistorted three-dimensional (3D) images of good quality with a low radiation dose (Yamamoto et al.,2003).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPG | – | Radiation: OPG & CBCT |
| CBCT | – | Radiation: OPG & CBCT |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- persons aged between 15 and 40 years.
Key inclusion criteria (2 listed)
- 1. Panoramic radiographs and cone beam computed tomography of patients aged15-40 years.
- 2. Only patients with a documented date of birth.
Key exclusion criteria (3 listed)
- 1. Asymmetry in OPG and CBCT images, unreadable ,unclear ,poor quality, gross pathology and magnification.
- 2. Panoramic radiographs with positioning errors which could cause distortions in the dimensions.
- 3. Hereditary facial asymmetries. 4. Images of completely edentulous patients. 5. Surgical intervention, patients with orthognathic surgeries. 6. Presence of pathologies such as fractures, impacted teeth, missing teeth, cleft lip or palate, cysts, tumors, osteomyelitis,severe osteoporosis in the mandible, periodontal lesion, and congenital craniofacial abnormalities, in the lower jaw, resorption in the mandibular arch that could affect the interpretation of radiographic image, 7. History of head trauma
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 |
|---|---|---|
| OPG & CBCTpanoramic images , cone beam computed tomography | Radiation | CBCT, OPG |
Primary outcome
comparison of OPG & CBCT
Time frame: Baseline
2. Comparison of the accuracy in identification of age and sex between using digital orthopantomographs and cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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Posture
Enrolling by invitation
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Dimensions, run by Assiut University.
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 3 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Eman Mahmoud Metwally, Demonstrator (01033343919 ext. 01017812151, emanmetwally53@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of OPG & CBCT (time frame: Baseline). 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 Jul 2021.