CTRI Number |
CTRI/2021/11/038006 [Registered on: 12/11/2021] Trial Registered Prospectively |
Last Modified On: |
03/11/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Magnification correction in orthopantomogram |
Scientific Title of Study
|
A pilot study to derive the measurements of PA cephalogram image using orthopantomogram and Lateral cephalogram images by estimating the magnification
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shailendra Singh Rana |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bathinda, Punajb |
Address |
Department of Dentistry, All India Institute of Medical Sciences, Bathinda
Bathinda PUNJAB 151001 India |
Phone |
08750146251 |
Fax |
|
Email |
rana.shailu0612@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Shailendra Singh Rana |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bathinda, Punajb |
Address |
Department of Dentistry, All India Institute of Medical Sciences, Bathinda
Bathinda PUNJAB 151001 India |
Phone |
08750146251 |
Fax |
|
Email |
rana.shailu0612@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shailendra Singh Rana |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bathinda, Punajb |
Address |
Department of Dentistry, All India Institute of Medical Sciences, Bathinda
Bathinda PUNJAB 151001 India |
Phone |
08750146251 |
Fax |
|
Email |
rana.shailu0612@gmail.com |
|
Source of Monetary or Material Support
|
Department of Dentistry, All India Institute of Medical, Bathinda, Punjab |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences Bathinda |
Address |
Department of Dentistry, All India Institute of Medical Sciences, Bathinda, Punajb |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
All India Institute of Medical Sciences |
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Akhilesh Pathak |
All India Institute of Medical Sciences, Bathinda |
Room No 3015, Department of Dentistry.
Bathinda PUNJAB |
08750146251
akpfmt@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
All India Institute of Medical Sciences, Bathinda, Institutional ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B||Imaging, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
• Non-syndromic patients
• Non cleft lip and palate patients
• No history of previous orthodontic treatments
• Patients radiographs available at least from forehead to inferior border of mandible
|
|
ExclusionCriteria |
Details |
Radiograph in which landmark is not clear |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The acquisition of the PA image can be avoided for the symmetry analysis if panoramic image has already been acquired. This will be helpful to reduce the radiation exposure to the patients. |
1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Non-Magnified orthopantomogram image |
1 year |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
01/01/2022 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
1.
Craniofacial symmetry is one of the elements of a balanced
facial appearance. Orthodontic and orthognathic surgery treatment is an effective method to achieve good
occlusion and create a balanced and harmonious facial appearance. However, every person has some asymmetry between the right and
left sides of the face and it ranges from clinically imperceptible to a gross
abnormality. The facial asymmetry might occur due to a combination of
genetic and environmental influences. Other causes of facial asymmetry include
trauma, infections, developmental abnormalities, myospasm, chronic muscle
shortening, or muscle splinting; syndromes such as Treacher Collins; occlusal
interferences; and joint pathologies such as rheumatoid arthritis, etc.
(1,2)Various tools have been used for the conventional diagnosis of facial
asymmetry. These might be clinical examination followed by photographs of
various frontal and side views, in addition to radiographs such as lateral and
posteroanterior cephalograms, oblique radiographs of the mandible taken at 45°,
and panoramic radiographs. (3,4) Three-dimensional modalities are used for the diagnosis of facial asymmetry, but these
have the disadvantages of radiation exposure and more cost. (5,6) Hence two-dimensional radiographs are commonly used for the diagnosis of facial asymmetry. In
these two dimensional radiographs, facial
symmetry is usually planned based on measurements from posteroanterior
(PA) encephalography. The cephalometric posteroanterior projection is a valuable tool in the
study of the right and left structures since they are located at equal distance
from the film and x-ray source Facial asymmetry and treatment results are objectively assessed concerning various cephalometric indices. (7,8) Many
morphologic studies have evaluated skeletal and soft tissue characteristics in
the frontal aspects using PA cephalometry for diagnosis and treatment
planning. (7,8)
These posteroanterior (PA) cephalograms are not the routine part of
orthodontic diagnosis radiograph and are required only for diagnosis of facial
asymmetry. Hence patient has an extra burden of cost and exposure to additional
radiographs. Another option to diagnose facial asymmetry
is the panoramic radiograph and considered the standard of care for orthodontic
and orthognathic diagnosis and treatment planning. It provides a significant
amount of information about the teeth and supporting bone and is used to screen
for cysts, cancer, extra teeth, the congenital absence or premature loss of
teeth, teeth fused to the bone or abnormally retained teeth, tooth eruption
path, bone pathology, and facial asymmetry. (9,10)
It is
also studied that conventional and digital panoramic films are plagued with
magnification errors and disproportional enlargement. (11-14)
Various
studies had been conducted to know the accuracy of asymmetry measurement with a panoramic radiograph. Tronje et al 15 mathematically calculated the accuracy of
panoramic measurements using an object composed of steel wires in a cross-formation to compare actual
measurements and calculated values to those taken from the radiograph. They
concluded that the panoramic film can be used for vertical but not for
horizontal measurements if the patient is properly positioned and has no marked
anatomic deviations from the norm. The accuracy of vertical measurements for
this panoramic unit was ±10% and therefore should not be relied on for high
accuracy. Large
and Svanaes 16 showed a
magnification factor of 18% to 21% for the vertical variables particularly in
the anterior region, but gonial angle measurements on the skulls were almost
identical to those measured on the panoramic image.
Kjellberg et al 17 found that on average, the condylion to gonion measurements from the panoramic films were magnified by 1.16 to 1.21 mm. Turp et al42 radiographed
concluded that panoramic radiographs are not appropriate for exact vertical
measurements such as condylar and ramus heights, or a combination, to assess
mandibular asymmetry. Batenburg et al 18 concluded that orthopantomography is not a reliable
technique to evaluate alveolar bone height in an edentulous mandible. Laster et
al 19 compared
horizontal and vertical measurements of anatomic points on 30 skulls imaged
with ideal, 7 mm laterally shifted, and 10° rotation around a vertical axis
positioning in a Sirona Orthophos Plus panoramic unit with measurements
obtained by software on digital images. It was concluded that the panoramic
accuracies in detecting mandibular asymmetry were 67%, 70%, and 47% for ideal,
rotated and shifted skull positions. Therefore, the assessment of posterior
mandibular facial symmetry with a panoramic unit was considered unreliable.
Based on findings of these studies it can be concluded
that orthopantomography is not a reliable radiograph to diagnose of asymmetry
due to magnification. Most practitioners do not use panoramic images for
asymmetry diagnosis. (11, 14)
Hence it is necessary to conduct a
study for the computation
of magnification factor of the OPG image and propose a software method to
correct the magnification factor of the OPG image for the derivation of the
measurements likely to measurements on PA image. |