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CTRI Number  CTRI/2021/12/038385 [Registered on: 02/12/2021] Trial Registered Prospectively
Last Modified On: 30/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To check the use of different bone thickness indicators studied in an full mouth xray image to detect decrease in bone mass. 
Scientific Title of Study   Evaluation of radiomorphometric indices on panoramic radiographs as a screening tool in the assessment of osteoporotic changes. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sridhar Javangula 
Designation  Post Graduate Student 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Oral Medicine and Radiology, Narayana Dental College and Hospital, Chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524002
India 
Phone  9618348163  
Fax    
Email  drsridharj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kannan N 
Designation  Professor and Head 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Oral Medicine and Radiology, Narayana Dental College and Hospital, Chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524002
India 
Phone  9490471078  
Fax    
Email  dentkan1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sridhar Javangula 
Designation  Post Graduate Student 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Oral Medicine and Radiology, Narayana Dental College and Hospital, Chinthareddypalem, Nellore.

Nellore
ANDHRA PRADESH
524002
India 
Phone  9618348163  
Fax    
Email  drsridharj@gmail.com  
 
Source of Monetary or Material Support  
Narayana Dental College and Hospital. 
 
Primary Sponsor  
Name  Narayana Dental College and Hospital 
Address  Chinthareddyypalem, Nellore, Andhra Pradesh, 524002 
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 
Sridhar Javangula  Narayana Dental College and Hospital  Department of Oral Medicine and Radiology
Nellore
ANDHRA PRADESH 		 9618348163

drsridharj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Narayana Dental College and Hospital.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Osteoporotic changes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Radiographs taken in the department of oral radiology which are clear and demarcated mental foramen and mandibular borders will be included in the study. 
 
ExclusionCriteria 
Details  Unclear radiographs and radiographs with intraosseous pathologies and fracture lines will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Trends in the values of three radiomorphometric indices in the age-groups and across the two genders included in the study.  One month - randomization and collection of samples and analysis.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   08/12/2021 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available on request to the principal investigator email id.

  6. For how long will this data be available start date provided 01-03-2022 and end date provided 28-02-2027?
    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  
     Digital panoramic radiographs of Sixty patients referred to the Department of Oral Radiology will be randomly selected using a convenience sampling method. An equal number will be maintained in the two age groups of less than and more than 45 years, in both the genders. This study was approved by the local Research Ethics Committee. The panoramic mandibular index (PMI), mental index (MI) and the gonial index (GI) will be analysed on each digital panoramic radiograph. As a part of the statistical analysis, Mann-Whitney ‘U’ test will be used to study the intra-group and inter-group correlations of the three indices and the significance values of the various indices will be compared between the age groups and the genders. The trends of these indices in the four groups will be assessed and their importance as screening tools for osteoporotic changes in the individuals will be evaluated.
 
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