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CTRI Number  CTRI/2024/11/076741 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [Measurements made on radiograph]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of two accuracy of different methods of age estimation using dental radiograph of mandibular second premolar 
Scientific Title of Study   Comparison of efficacy of Cameriere’s and Drusini’s methods of age estimation in Indian adults using radiographs of mandibular second premolar-  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1315-5674  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meru S 
Designation  Professor and Head dept of Oral Medicine andRadiology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No 1, Dept of Oral Medicine and Radiology, Uttaranchal Dental and Medical Research Institute, Majri grant, Haridwar road

Dehradun
UTTARANCHAL
248140
India 
Phone  8126192404  
Fax    
Email  drmeru@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Meru S 
Designation  Professor and Head dept of Oral Medicine andRadiology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No. 1, Dept of Oral Medicine and Radiology, Uttaranchal Dental and Medical Research Institute, Majri grant, Haridwar road


UTTARANCHAL
248140
India 
Phone  8126192404  
Fax    
Email  drmeru@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meru S 
Designation  Professor and Head dept of Oral Medicine andRadiology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  oom No. 1, Dept of Oral Medicine and Radiology, Uttaranchal Dental and Medical Research Institute, Majri grant, Haridwar road


UTTARANCHAL
248140
India 
Phone  8126192404  
Fax    
Email  drmeru@gmail.com  
 
Source of Monetary or Material Support  
Uttaranchal Dental and Medical Research Institute 
 
Primary Sponsor  
Name  Uttaranchal Dental and Medical Research Institute 
Address  Maji grant, Haridwar road 
Type of Sponsor  Other [Private dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Meru S  Uttaranchal Dental and Medical Research Institute  oom No. 1, Dept of Oral Medicine and Radiology, Majri grant, Haridwar road
Dehradun
UTTARANCHAL 		 8126192404

drmeru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Uttaranchal Dental and Medical Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Actual age   Biological age based on date of birth will be used to assess the accuracy of estimated age by both the test techniques. 
Intervention  Cameriere’s method of age estimation  Retrospectively retrieve the Periapical radiographs taken using paralleling technique from dental patients for diagnosing dental diseases in molars with intact mandibular second premolars from the dental records of the department. measurement of area of crown and area of pulp chamber will be made Image J. the values will be used to arrive at a regression formula for age estimation. estimated age will be compared with biological age based on date of birth to assess the accuracy of this method. Recording of the measurements on the radiograph takes up to 10 minutes per radiograph  
Intervention  Drusini’s method of age estimation  Retrospectively retrieve the Periapical radiographs taken using paralleling technique from dental patients for diagnosing dental diseases in molars with intact mandibular second premolars from the dental records of the department. measurement of height of crown and height of pulp chamber will be made Image J. the values will be used to arrive at a regression formula for age estimation. estimated age will be compared with biological age based on date of birth to assess the accuracy of this method. Recording of the measurements on radiograph takes upto 5 minutes per radiographs.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Periapical radiographs of mandibular premolar seen completely.
Intact tooth structure of mandibular second premolar.
Radiographs of patients with their date of birth available.
Date of radiography is available 
 
ExclusionCriteria 
Details  Poor quality images.
Patients where date of birth is not recorded.
loss of tooth structure in mandibular premolar due to dental caries.
Those with date of radiography is not available 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Height and area of crown of mandibular second premolar.
Height and area of pulp chamber of mandibular second premolar 		 one time after the radiograph is selected for including in the study 
 
Secondary Outcome  
Outcome  TimePoints 
age estimation using both the methods  one time after the radiograph is selected for including into the study 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drmeru@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 31-07-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary       The aim of this study was to investigate the applicability and accuracy of Drusini’s and Cameriere’s methods of age estimation in Indian adult population.
Method: 150 periapical radiographs pf mandibular second premolar radiographs obtained from dental patients. Measurements of height of pulp chamber and crown and area of pulp chamber and crown will be made. The values obtained will be used to obtain regression co- efficient to apply in Drusini’s and Cameriere’s formula.
Pearson’s correlation coefficients and regression analysis will be used.

 
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