Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232135
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2024-01-20
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:
Cairo University
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 462R 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 462R 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 manufacturers recommendations
Images with 04 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 hisher 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 005 a beta of 02 ie power80 and an effect size d of 026 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 GPower version 3197 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 005 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 manufacturers recommendations
Images with 04 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 hisher 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 005 a beta of 02 ie power80 and an effect size d of 026 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 GPower version 3197 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 005 for all tests Statistical analysis will be performed with IBM SPSS Statistics Version 26 for Windows
Study Oversight
Has Oversight DMC:
None
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?:
None