Estimated Age Calculated Based on Modified Demirjian Method Using Mandibular Left Third MolarNCT06232135
Assessment of Reliability of Demirjian Formula for Age Estimation Using Mandibular Third Molar in a Sample of Egyptian Population Using CBT: a Cross-sectional Study
An observational study of Estimated Age Calculated Based on Modified Demirjian Method Using Mandibular Left Third Molar, run by Cairo University at 1 site in Egypt.
Trial summary
Aim: To assess the reliability of age estimation in Egyptian adolescents and young adults using mandibular third molar stages of calcification, based on the Demirjian method, on CBCT scans. Read more about this study
- Who is it for?
- Ages 9 to 24 years
- Conditions the study is for
- Estimated Age Calculated Based on Modified Demirjian Method Using Mandibular Left Third Molar
- What is being tested?
- CBCT scan
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 15 Jun 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 9 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: CBCT scans from the database available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.
Who may be able to join
- Egyptian patients with age ranges from 9 to 24 years.
- Complete dental records of radiographs, including the date of birth, date of radiography, and sex.
- Scans showing complete mandibular arch.
Who cannot join
- Patients below 9 years and above 24 years.
- Any pathology or fractures associated with mandibular third molar.
- Scans with severe metallic artifacts.
- Congenitally absent 3rd molars.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry - Cairo university
Cairo, Cairo Governorate, 3753450
About this study
Aim: To assess the reliability of age estimation in Egyptian adolescents and young adults using mandibular third molar stages of calcification, based on the Demirjian method, on CBCT scans.
Methodology: 145 CBCT scans for the mandibular left posterior region were collected from the database of the maxillofacial radiology clinic of the faculty of dentistry at Cairo University. The scans were then analyzed using Planmeca Romexis software viewer version 4.6.2.R. The mandibular left 3rd molars were evaluated to determine the calcification stage of each of them based on the modified Demirjian method. According to the assigned calcification stage, the dental age was determined, and then the mean ± SD for each calcification stage was calculated and compared to the chronological age in terms of mean difference and mean absolute error. The correlation between the calculation stage and chronological age was analyzed, and the probability for an individual to be 18 years of age or older in each stage was calculated.
Read the detailed description
this is a cross-sectional study.
The data collection will be obtained from the database available at the Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in the oral and maxillofacial radiology departments for different purposes.
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
- Images with 0.4 voxel size or less will be reviewed.
- Evaluation of the calcification of third molar will be done using the reformatted panoramic view of CBCT scans and will be compared with the Demirjian chart (8 stage grading scheme for third molar).
- The third molars from the lower left quadrants will be assessed and categorized into their respective developmental stages given by Demirjian.
- CBCT images will be interpreted by two oral and maxillofacial radiologists (with different experiences) independently; blinded from demographic data of the patients and from the results of each other.
- Each radiologist will evaluate the images for proper determination of the third molar calcification stage and to decide the dental age of the patient according the chart provided by demirjian et al.
- The calcification stage determination will be carried out by one observer and will be repeated later for intra-observer reliability assessment.
- Any disagreement will be solved by consensus between the two observers.
- The chronological age recorded based on his/her date of birth will be correlated with developmental stages of third molar.
The two oral and maxillofacial radiologists interpreting the scans will be blinded from demographic data of the patients and from the results of each other.
A power analysis was designed to have adequate power to apply a statistical test of the null hypothesis that there is no difference would be found between chronological age and developmental age of third molar according to modified Demirjian chart. By adopting an alpha level of (0.05) a beta of (0.2) i.e. power=80% and an effect size (d) of (0.26) calculated based on the results of Mohammed, Rezwana Begum, et al. ; the predicted sample size (n) was a total of (117) cases. Sample size calculation was performed using G*Power version 3.1.9.7 Numerical data will be explored for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was found to be normally distributed, it will be presented as mean and standard deviation values. If the assumption of normality was found to be violated, the data will be presented as median and range values.
Categorical data will be represented as frequency (n) and percentage (%). Categorical data will be represented as frequency (n) and percentage (%) and will be analyzed using chi square test. Numerical data will be explored for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was found to be normally distributed, it will be presented as mean and standard deviation values and Paired t-test will be used for the analysis. If the assumption of normality was found to be violated; the data will be presented as median and range values and will be analyzed using Wilcoxon signed-rank test. The significance level will be set at p ≤0.05 for all tests. Statistical analysis will be performed with IBM® SPSS® Statistics Version 26 for Windows.
- Conditions
- Estimated Age Calculated Based on Modified Demirjian Method Using Mandibular Left Third Molar
- Being tested
- CBCT scan
- Keywords
- Demirjian, CBCT, age estimation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT scanOther
analysis of the CBCT scan to assign a calcification stage to the subject's lower left third molar and accordingly calculate the estimated age of each subject
| Study group | Role | What they receive |
|---|---|---|
| Females | CBCT scans of the females enrolled in the study are to be analyzed for the assignment of a calcification stage to their lower left third molar according to the modified Demirjian method. Receives: Other: CBCT scan | |
| Males | CBCT scans of the males enrolled in the study are to be analyzed for the assignment of a calcification stage to their lower left third molar according to the modified Demirjian method. Receives: Other: CBCT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the modified Demirjian method
mean difference between estimated age and chronological age
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Sep 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estimated Age Calculated Based on Modified Demirjian Method Using Mandibular Left Third MolarStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Aladdin Mohamed Shaaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232135
- Sponsor's protocol ID
- yaraprotocol1893
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The age and gender of the participants will be shared. If further information is required, then the invistigator will decide what to share so as not to violate patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reliability of Demirjian Formula for Age Estimation Using Mandibular Third Molar in a Sample of Egyptian Population Using CBT: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06232135
- Acronym / sponsor ID
- yaraprotocol1893
- Conditions
- Estimated Age Calculated Based on Modified Demirjian Method Using Mandibular Left Third Molar
- Keywords
- Demirjian, CBCT, age estimation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 30 Jan 2024 (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.
Aim: To assess the reliability of age estimation in Egyptian adolescents and young adults using mandibular third molar stages of calcification, based on the Demirjian method, on CBCT scans.
Methodology: 145 CBCT scans for the mandibular left posterior region were collected from the database of the maxillofacial radiology clinic of the faculty of dentistry at Cairo University. The scans were then analyzed using Planmeca Romexis software viewer version 4.6.2.R. The mandibular left 3rd molars were evaluated to determine the calcification stage of each of them based on the modified Demirjian method. According to the assigned calcification stage, the dental age was determined, and then the mean ± SD for each calcification stage was calculated and compared to the chronological age in terms of mean difference and mean absolute error. The correlation between the calculation stage and chronological age was analyzed, and the probability for an individual to be 18 years of age or older in each stage was calculated.
Detailed description
this is a cross-sectional study.
The data collection will be obtained from the database available at the Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in the oral and maxillofacial radiology departments for different purposes.
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
- Images with 0.4 voxel size or less will be reviewed.
- Evaluation of the calcification of third molar will be done using the reformatted panoramic view of CBCT scans and will be compared with the Demirjian chart (8 stage grading scheme for third molar).
- The third molars from the lower left quadrants will be assessed and categorized into their respective developmental stages given by Demirjian.
- CBCT images will be interpreted by two oral and maxillofacial radiologists (with different experiences) independently; blinded from demographic data of the patients and from the results of each other.
- Each radiologist will evaluate the images for proper determination of the third molar calcification stage and to decide the dental age of the patient according the chart provided by demirjian et al.
- The calcification stage determination will be carried out by one observer and will be repeated later for intra-observer reliability assessment.
- Any disagreement will be solved by consensus between the two observers.
- The chronological age recorded based on his/her date of birth will be correlated with developmental stages of third molar.
The two oral and maxillofacial radiologists interpreting the scans will be blinded from demographic data of the patients and from the results of each other.
A power analysis was designed to have adequate power to apply a statistical test of the null hypothesis that there is no difference would be found between chronological age and developmental age of third molar according to modified Demirjian chart. By adopting an alpha level of (0.05) a beta of (0.2) i.e. power=80% and an effect size (d) of (0.26) calculated based on the results of Mohammed, Rezwana Begum, et al. ; the predicted sample size (n) was a total of (117) cases. Sample size calculation was performed using G*Power version 3.1.9.7 Numerical data will be explored for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was found to be normally distributed, it will be presented as mean and standard deviation values. If the assumption of normality was found to be violated, the data will be presented as median and range values.
Categorical data will be represented as frequency (n) and percentage (%). Categorical data will be represented as frequency (n) and percentage (%) and will be analyzed using chi square test. Numerical data will be explored for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was found to be normally distributed, it will be presented as mean and standard deviation values and Paired t-test will be used for the analysis. If the assumption of normality was found to be violated; the data will be presented as median and range values and will be analyzed using Wilcoxon signed-rank test. The significance level will be set at p ≤0.05 for all tests. Statistical analysis will be performed with IBM® SPSS® Statistics Version 26 for Windows.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females | – | Other: CBCT scanCBCT scans of the females enrolled in the study are to be analyzed for the assignment of a calcification stage to their lower left third molar according to the modified Demirjian method. |
| Males | – | Other: CBCT scanCBCT scans of the males enrolled in the study are to be analyzed for the assignment of a calcification stage to their lower left third molar according to the modified Demirjian method. |
Who may qualify
- Ages
- 9 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- CBCT scans from the database available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.
Key inclusion criteria (3 listed)
- Egyptian patients with age ranges from 9 to 24 years.
- Complete dental records of radiographs, including the date of birth, date of radiography, and sex.
- Scans showing complete mandibular arch.
Key exclusion criteria (4 listed)
- Patients below 9 years and above 24 years.
- Any pathology or fractures associated with mandibular third molar.
- Scans with severe metallic artifacts.
- Congenitally absent 3rd molars.
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 |
|---|---|---|
| CBCT scananalysis of the CBCT scan to assign a calcification stage to the subject's lower left third molar and accordingly calculate the estimated age of each subject | Other | Females, Males |
Primary outcome
accuracy of the modified Demirjian method
Time frame: 2 weeks
mean difference between estimated age and chronological age
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 30 Jan 2024.
- Individual participant dataSharing planned: Undecided. The age and gender of the participants will be shared. If further information is required, then the invistigator will decide what to share so as not to violate patient privacy.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Estimated Age Calculated Based on Modified Demirjian Method Using Mandibular Left Third Molar, 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 3 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: finished, as of the sponsor's last update on 30 Jan 2024. 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?
accuracy of the modified Demirjian method (time frame: 2 weeks). 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 30 Jan 2024.