| CTRI Number |
CTRI/2021/12/038699 [Registered on: 16/12/2021] Trial Registered Prospectively |
| Last Modified On: |
17/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of size and shape of condyle of lower jaw and its variations. |
|
Scientific Title of Study
|
Evaluation of condylar morphology and its variations using digital panoramic radiographs-A Retrospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaik Arshiya |
| Designation |
postgraduate |
| Affiliation |
Narayana dental college and hospital |
| Address |
Dept of oral medicine and radiology
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Dept of oral medicine and radiology
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9177133737 |
| Fax |
0861-23-5092 |
| Email |
arshiyashaik812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N kannan Natrajan |
| Designation |
Head of the department and professor |
| Affiliation |
Narayana dental college and hospital |
| Address |
Dept of oral medicine and radiology
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Dept of oral medicine and radiology
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9490471078 |
| Fax |
0861-23-5092 |
| Email |
dentkan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaik Arshiya |
| Designation |
postgraduate |
| Affiliation |
Narayana dental college and hospital |
| Address |
Dept of oral medicine and radiology
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Dept of oral medicine and radiology
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9177133737 |
| Fax |
0861-23-5092 |
| Email |
arshiyashaik812@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Narayana dental college and hospital |
| Address |
Dept of oral medicine and radiology
Narayana Dental College and Hospital
Chintareddypalem
Nellore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sk Arshiya |
Narayana Dental College and Hospital |
Narayana Dental College and Hospital C R Palem Nellore
Nellore
ANDHRA PRADESH |
9177133737
08612305092
arshiyashaik812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
good quality digital panoramic radiographs where condyles can be clearly visualized will be selected for the study
Data of digital panoramic radiographs of the patients above the age of 18 years will be taken for the study |
|
| ExclusionCriteria |
| Details |
POOR QUALITY IMAGES |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
DEVELOPING DATABASE OF THE
NORMAL MORPHOLOGICAL CHARACTERISTICS OF THE MANDIBULAR CONDYLE |
1year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Develop Basis for Identifying Pathological Changes in the Condyle |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="2500"
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)
|
27/12/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be Done after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
2500 Good Quality Digital Panoramic radiographs will be screened and analyzed according to inclusion criteria to identify the morphological characteristics and variations of the condyles, which will be interpreted as per guidelines developed by Hegde et al. The Condylar shapes will be evaluated and compared for both sides and between both the sexes 2500 digital panoramic radiographs will be examined radiographically to measure the dimensions of the right and left condyles from the superior-inferior and anterior-posterior region using the inbuilt measurement tool given by the software and the length will be measured. The values will be tabulated and statistically analyzed with SPSS version and a chi-square test will be used for analysis. |