HealthyNCT05130164
Age Estimation From Pulp Cavity Analysis Using Cone Beam Computed Tomographic Images for Forensic Purposes
An observational study of Healthy, run by Cairo University at 1 site in Egypt.
Trial summary
Forensic odontology is a branch of forensic science that utilizes a dentist's expertise in identification of individuals for whom traditional methods of identification aren't accessible due to a lack of common identification features. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CBCT
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2022to Dec 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: CBCT scans that meet the eligibility criteria for age estimation
Who may be able to join
- CBCT scans for male and female Egyptians between the ages of 20 and 60 years.
- CBCT scans with the required complement of teeth.
Who cannot join
- CBCT scans that lack a proof of age or date of birth.
- CBCT scans with the required teeth showing pathological processes in the apical bone.
- CBCT scans with overlying teeth.
- CBCT scans in which the required teeth were filled, prosthetically restored or carious.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo university
Cairo
Christine Beshara, 01273539853, christine.beshara@dentistry.cu.edu.eg
About this study
Official title: Forensic Assessment of Age From Pulp Cavity Using Cone Beam Computed Tomographic Images (An Observational Cross- Sectional Study)
Forensic odontology is a branch of forensic science that utilizes a dentist's expertise in identification of individuals for whom traditional methods of identification aren't accessible due to a lack of common identification features. Medico-legal issues, natural catastrophes such as tsunamis, earthquakes, and explosions, death verification in monetary concerns, religious and social reasons are all examples of situations that require identification. Age, stature, sex and ethnicity are the "big four" determinants of personal identification. Dental age estimation has the benefit of that teeth are less influenced by external physical, chemical, or mechanical variables than other portions of the skeleton. Secondary dentin deposition in human teeth progresses with age that results in reduction in the size of the tooth pulp cavity which can be assessed as an age indicator. A significant relationship between pulp width and age was originally discovered in a study by Kvaal et al., 1995 who created regression formulae for age prediction using periapical radiograph by measuring of pulp size. Also, the assessment of pulp/tooth volume ratio relying on the gradual reduction in pulp volume produced by continuous apposition of dentin during life is one well-known dental age estimation approach. Cone beam computed tomography (CBCT) provides accurate three-dimensional images of the maxillofacial area. In addition, CBCT may be beneficial in some forensic situations, as it has massive benefits for post-mortem forensic imaging, as it offers skeletal imaging with high resolution, cheap cost, simplicity and portability. CBCT can be used in forensic age assessment since it is non-invasive and allows for the reconstruction of images in multiple planes to display anatomical and imaged elements in distinct planes. Our hypothesis is that pulp space analysis is totally different between different ages and that there is a correlation between age and pulp space analysis that could be of a forensic significance for age estimation in the investigated population.
Read the detailed description
In this observational cross-sectional study, cone beam computed tomography scans will be recruited that are with the required complement of teeth and in the age range between 20 and 60 years then, correlation between chronological age versus cone beam computed tomography age through pulp space analysis will be done by two methods which are linear measurements and volumetric measurements of pulp and tooth size. First, linear measurements will be done according to kvaal's et al approach, measurements from mandibular lateral incisors, canines and first premolars and maxillary central and lateral incisors and second premolars were most strongly correlated with age, so these teeth will be selected for the investigation. A paired t-test on these measurements showed that there were no significant differences between teeth from the left and the right side of the jaw. Consequently, teeth from either the left or the right side will be chosen, whichever will be best suited for measurement. Not knowing the age and gender of the individual, the following measurements will be carried out on the radiographs of all six types of teeth: the maximum tooth length (T), pulp length and root length (R) on the mesial surface from the enamel-cementum junction (ECJ) to the root apex, the root and pulp width both at the ECJ (level A) and at the midroot level, i.e. halfway between the ECJ and the apex of the root (level C), as well as at the midpoint between the ECJ and midroot level (level B). Second, volumetric Measurements will be done to calculate pulp/ tooth volume ratio.
- Conditions
- Healthy
- Being tested
- CBCT
- Keywords
- CBCT, Forensic dentistry, Age determination by teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
Cone beam computed tomographic images selected for age estimation
| Study group | Role | What they receive |
|---|---|---|
| Single group | Single group will be selected for age estimation using CBCT Scans Receives: Radiation: CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp/ tooth volume ratio CBCT age to be correlated with chronological age
Pulp/ tooth volume ratio CBCT age to be correlated with chronological age using volumetric segmentation of CBCT software in mm3.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Analysis of pulp size using linear measurements.
Analysis of pulp size using linear measurements tool of CBCT software in mm.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start2 Apr 2022
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Atef Banoub Beshara, Cairo University
- Investigators
- Christine Beshara, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130164
- Sponsor's protocol ID
- Christine Atef ORAD 7-1-1
- Status last verified
- Aug 2022
- First submitted
- 8 Nov 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asif MK, Nambiar P, Mani SA, Ibrahim NB, Khan IM, Lokman NB. Dental age estimation in Malaysian adults based on volumetric analysis of pulp/tooth ratio using CBCT data. Leg Med (Tokyo). 2019 Feb;36:50-58. doi: 10.1016/j.legalmed.2018.10.005. Epub 2018 Oct 21.
PubMed 30415192
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forensic Assessment of Age From Pulp Cavity Using Cone Beam Computed Tomographic Images (An Observational Cross- Sectional Study)
- ClinicalTrials.gov ID
- NCT05130164
- Acronym / sponsor ID
- Christine Atef ORAD 7-1-1
- Conditions
- Healthy
- Keywords
- CBCT, Forensic dentistry, Age determination by teeth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Nov 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.
Forensic odontology is a branch of forensic science that utilizes a dentist's expertise in identification of individuals for whom traditional methods of identification aren't accessible due to a lack of common identification features. Medico-legal issues, natural catastrophes such as tsunamis, earthquakes, and explosions, death verification in monetary concerns, religious and social reasons are all examples of situations that require identification. Age, stature, sex and ethnicity are the "big four" determinants of personal identification. Dental age estimation has the benefit of that teeth are less influenced by external physical, chemical, or mechanical variables than other portions of the skeleton. Secondary dentin deposition in human teeth progresses with age that results in reduction in the size of the tooth pulp cavity which can be assessed as an age indicator. A significant relationship between pulp width and age was originally discovered in a study by Kvaal et al., 1995 who created regression formulae for age prediction using periapical radiograph by measuring of pulp size. Also, the assessment of pulp/tooth volume ratio relying on the gradual reduction in pulp volume produced by continuous apposition of dentin during life is one well-known dental age estimation approach. Cone beam computed tomography (CBCT) provides accurate three-dimensional images of the maxillofacial area. In addition, CBCT may be beneficial in some forensic situations, as it has massive benefits for post-mortem forensic imaging, as it offers skeletal imaging with high resolution, cheap cost, simplicity and portability. CBCT can be used in forensic age assessment since it is non-invasive and allows for the reconstruction of images in multiple planes to display anatomical and imaged elements in distinct planes. Our hypothesis is that pulp space analysis is totally different between different ages and that there is a correlation between age and pulp space analysis that could be of a forensic significance for age estimation in the investigated population.
Detailed description
In this observational cross-sectional study, cone beam computed tomography scans will be recruited that are with the required complement of teeth and in the age range between 20 and 60 years then, correlation between chronological age versus cone beam computed tomography age through pulp space analysis will be done by two methods which are linear measurements and volumetric measurements of pulp and tooth size. First, linear measurements will be done according to kvaal's et al approach, measurements from mandibular lateral incisors, canines and first premolars and maxillary central and lateral incisors and second premolars were most strongly correlated with age, so these teeth will be selected for the investigation. A paired t-test on these measurements showed that there were no significant differences between teeth from the left and the right side of the jaw. Consequently, teeth from either the left or the right side will be chosen, whichever will be best suited for measurement. Not knowing the age and gender of the individual, the following measurements will be carried out on the radiographs of all six types of teeth: the maximum tooth length (T), pulp length and root length (R) on the mesial surface from the enamel-cementum junction (ECJ) to the root apex, the root and pulp width both at the ECJ (level A) and at the midroot level, i.e. halfway between the ECJ and the apex of the root (level C), as well as at the midpoint between the ECJ and midroot level (level B). Second, volumetric Measurements will be done to calculate pulp/ tooth volume ratio.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Radiation: CBCTSingle group will be selected for age estimation using CBCT Scans |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- CBCT scans that meet the eligibility criteria for age estimation
Key inclusion criteria (2 listed)
- CBCT scans for male and female Egyptians between the ages of 20 and 60 years.
- CBCT scans with the required complement of teeth.
Key exclusion criteria (4 listed)
- CBCT scans that lack a proof of age or date of birth.
- CBCT scans with the required teeth showing pathological processes in the apical bone.
- CBCT scans with overlying teeth.
- CBCT scans in which the required teeth were filled, prosthetically restored or carious.
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 |
|---|---|---|
| CBCTCone beam computed tomographic images selected for age estimation | Radiation | Single group |
Primary outcome
Pulp/ tooth volume ratio CBCT age to be correlated with chronological age
Time frame: Through study completion, an average of 1 year
Pulp/ tooth volume ratio CBCT age to be correlated with chronological age using volumetric segmentation of CBCT software in mm3.
1 secondary outcome
Analysis of pulp size using linear measurements.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Results publication: PubMed 30415192Asif MK, Nambiar P, Mani SA, Ibrahim NB, Khan IM, Lokman NB. Dental age estimation in Malaysian adults based on volumetric analysis of pulp/tooth ratio using CBCT data. Leg Med (Tokyo). 2019 Feb;36:50-58. doi: 10.1016/j.legalmed.2018.10.005. Epub 2018 Oct 21.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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.
Christine Beshara principal investigator
Cairo 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 Healthy, 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 4 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 30 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Beshara (+201273539853, christine.beshara@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp/ tooth volume ratio CBCT age to be correlated with chronological age (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05130164, which also lists 1 linked publication.
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 30 Aug 2022.