Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 8:55 AM
Study NCT ID:
NCT06232135
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2024-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Cairo University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: