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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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