CTRI Number |
CTRI/2023/06/053858 [Registered on: 14/06/2023] Trial Registered Prospectively |
Last Modified On: |
13/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Radiation Therapy Dentistry |
Study Design |
Other |
Public Title of Study
|
A comparative evaluation between 2-D and 3-D radiographic images for detection of apical root resorption |
Scientific Title of Study
|
A comparative evaluation between two dimensional and three dimensional radiographic images for detection of apical root resorption during orthodontic treatment - a prospective study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shivika Garg |
Designation |
2nd Year Post Graduate Student |
Affiliation |
subharti dental college and hospital |
Address |
department of orthodontics and dentofacial orthopaedics Subharti
Dental College and Hospital, Swami Vivekanand Subharti University, Meerut
Meerut UTTAR PRADESH 250005 India |
Phone |
9035313052 |
Fax |
|
Email |
shivika8@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pradeep Raghav |
Designation |
Professor and Head Department of Orthodontics |
Affiliation |
Subharti Dental College and Hospital |
Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti
Dental College and Hospital, Swami Vivekanand Subharti University,
Meeru
Meerut UTTAR PRADESH 250005 India |
Phone |
9837175914 |
Fax |
|
Email |
drpradeepraghav@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pradeep Raghav |
Designation |
Professor and Head Department of Orthodontics |
Affiliation |
Subharti Dental College and Hospital |
Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti
Dental College and Hospital, Swami Vivekanand Subharti University,
Meeru
Meerut UTTAR PRADESH 250005 India |
Phone |
9837175914 |
Fax |
|
Email |
drpradeepraghav@gmail.com |
|
Source of Monetary or Material Support
|
department of orthodontics and dentofacial orthopaedics, subharti dental college and hospital, Swami Vivekanand Subharti University, Meerut |
|
Primary Sponsor
|
Name |
Dr Shivika Garg |
Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti
Dental College and Hospital, Swami Vivekanand Subharti University,
Meerut |
Type of Sponsor |
Other [self supported] |
|
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 |
Dr Shivika Garg |
Subharti Dental College and Hospita |
Department of
Orthodontics and
Dentofacial Orthopedics
Room No.7 2nd Floor
Subharti Dental College
and Hospital, Swami
Vivekanand Subharti
University, Meerut Meerut UTTAR PRADESH |
9035313052
shivika8@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institution of ethical committee, subharti dental college |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
post treatment radiographs |
CBCT and IOPA of patients undergoing orthodontic treatment after 1 year |
Intervention |
pre treatment radiographs |
CBCT and IOPA of patients undergoing orthodontic treatment - on the 1st day |
|
Inclusion Criteria
|
Age From |
11.00 Year(s) |
Age To |
25.00 Year(s) |
Gender |
Both |
Details |
1. Healthy patient with angle class 1 & 2 malocclusion
2. Permanent dentition
3. Anterior Crowding of 3-4 mm
4. Absence of caries
5. Absence of periodontitis
6. Clear images of CBCT
|
|
ExclusionCriteria |
Details |
1. History of previous orthodontic treatment
2. Bruxism
3. Traumatic injuries
4. Crown or root fractures
5. Severely dilacerated roots
6. Congenitally missing laterals
7. Incomplete root formation at the start of treatment
8. Maxillary incisors with caries
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
to compare two dimensional and three dimensional radiographic images for detection of apical root resorption during orthodontic treatment |
After 1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
to compare two dimensional and three dimensional radiographic images for detection of apical root resorption during orthodontic treatment |
1 year |
|
Target Sample Size
|
Total Sample Size="18" Sample Size from India="18"
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)
|
24/06/2023 |
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
|
none |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
One of the many consequences of orthodontic treatment is root resorption, which cannot be overlooked. The root resorption associated with orthodontic treatment is external and apical in nature. It tends to occur when pressure over the cementum overcomes the reparative capacity of the innermost cellular structures. Root resorption starts adjacent to hyalinised tissues and is associated with the removal of the zone of necrosis. In some of the patients root resorption is minor, however most of the cases show different levels of root resorption. Root resorption is not caused by a single but numerous factors as reviewed by Brezniak and Wasserstein. These factors include morphological features, biological features and a combination of both. For mechanical factors, the extensive tooth movement, root torque and intrusive forces, orthodontic force magnitude, duration and type of force are involved. Whereas for biological factors, genetic susceptibility, systemic factors (hormone imbalance), teeth agenesis, and medication intake influence the root resorption. The highest prevalence for root resorption is observed in upper lateral incisors followed by upper central incisors. In orthodontics, radiographic assessment is an essential diagnostic tool to detect root resorption. Previously histologic methods had been used for determination of root resorption but it has its own difficulties such as they are done in vitro on extracted teeth or are animal studies. The radiographic examination includes usage of two dimensional images such as intraoral periapical films, panoramic films. While periapical images via the paralleling technique is the current gold standard for measuring root resorption. In present era, CBCT is the most frequently used three dimensional methods as it depicts 2D views in all 3 dimensions (axial, coronal and sagittal). Both the methods have their own advantages and disadvantages. Usage of two dimensional images has its own benefits like easiness and low radiation levels, however it also has its own downsides that are incorrect projection and magnification. On the other hand, three dimensional scans use higher radiation levels but measures it with more accuracy. Also they overcome orientation errors and overlapping problems. Many clinical studies have been published to evaluate the magnitude of root resorption but there is still a need for the comparison amongst two dimensional and three dimensional methods so as to know which method is superior and more accurate. Furthermore, no information has been specified about the amount of root resorption occurring on the labial or lingual surfaces previously. Thus the aim of the study is to compare the amount of the external apical root resorption between the 2 dimensional and 3 dimensional images of maxillary incisors resorption before the initiation of treatment and after the completion of space closure. |