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CTRI Number  CTRI/2024/08/072319 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Evaluation of roots of upper canine tooth when two different amount of force will be applied to them with the help of CBCT 
Scientific Title of Study   Evaluation Of External Apical Root Resorption Associated With Canine Retraction With Two Different Amounts Of Orthodontic Loads: A CBCT Split Mouth Design Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mitesh Mithaiwala 
Designation  MDS - Orthodontics Post Graduation 
Affiliation  Manubhai Patel Dental College 
Address  1st floor, Department of Orthodontics, Manubhai Patel Dental College, Muj Mahuda, Vadodara

Vadodara
GUJARAT
390020
India 
Phone  7069943491  
Fax    
Email  dhwanimithaiwala11923@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. KALPESH PATEL 
Designation  HOD, Department of Orthodontics 
Affiliation  Manubhai Patel Dental College 
Address  1st floor, Department of Orthodontics, Manubhai Patel Dental College, Muj Mahuda, Vadodara

Vadodara
GUJARAT
390020
India 
Phone  9898107502  
Fax    
Email  dr_kalpeshp@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  MITESH MITHAIWALA 
Designation  MDS - Orthodontics Post Graduation  
Affiliation  Manubhai Patel Dental College 
Address  1st floor, Department of Orthodontics, Manubhai Patel Dental College, Muj Mahuda, Vadodara

Vadodara
GUJARAT
390020
India 
Phone  7069943491  
Fax    
Email  dhwanimithaiwala11923@gmail.com  
 
Source of Monetary or Material Support  
1st floor, Department of Orthodontics, Manubhai Patel Dental College, Muj Mahuda, Vadodara 
 
Primary Sponsor  
Name  Mitesh Mithaiwala 
Address  1st floor, Department of Orthodontics, Manubhai Patel Dental College, Muj Mahuda, Vadodara 
Type of Sponsor  Other [SELF] 
 
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 Kalpesh Patel  MANUBHAI PATEL DENATL COLLEGE  DEPARTMENT OF ORTHODONTICS, MANUBHAI PATEL DENTAL COLLEGE, MUJ MAHUDA CIRCLE, VADODARA
Vadodara
GUJARAT 		 9898107502

dr_kalpeshp@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients requiring therapeutic extraction of bilateral upper first premolars as a part of the treatment.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients requiring therapeutic extraction of bilateral upper first premolars as a part of the treatment.
Good oral hygiene and healthy periodontium
Patient between age 16 -30 year will be included in this study.
 
 
ExclusionCriteria 
Details  Patients who do not give consent for the study
Poor oral hygiene
Patients with compromised periodontium
Non extraction cases
Patients with Systemic illnesses like Diabetes mellites, AIDS, patients on medication like phenytoin, or immunosuppressants.
Patients with missing teeth in the anterior region
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Their will be sign of External Apical Root resorption where application of force will be more during Orthodontic treatment in maxillary region and will be evaluated with help of CBCT.  4 MONTHS TO 7 MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
Their will be no sign of external apical root resorption after application of two different amount of orthodontic loads on canine tooth in maxillary region during orthodontic treatment after evaluation of CBCT.   4 Months to 7 months 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
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)   24/08/2024 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 05-01-2024 and end date provided 06-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

•       This will be a split mouth in-vivo study. 19 patients (age group between 16 years and 30 years) undergoing orthodontic treatment requiring extraction of 1st premolar as a part of orthodontic treatment will be selected for the study. The maxillary teeth will be well aligned, before retraction of canine. Each participant will be treated with fixed pre-adjusted appliance. The system used will be metal 0.022 x 0.028” slot MBT bracket system. The timeframe of the study will be between 4 months to 7 months as according to research, this much time is generally needed for canine retraction. Minimum 19 samples will be included in this study. Participants will be allocated into 2 sides using lottery method: one side of the maxillary region will be delivered with 100gm of orthodontic load and the other side of maxillary region will be delivered with 200gm of force. This force will be measured by standardized Dontrix Gauge.

•       All CBCT scans will be performed by the same standardized CBCT machine (Vera view Pox R-200) The scans of each subject will be taken immediately before and after the canine retraction. The same setting will be used for all scans. The EARR will be quantified by using the CBCT scans obtained immediately before and after canine retraction. The CBCT images will be processed with soft view CBCT software (idixel by Jmonita Japan).

•        

•       Before the study, the right and left first premolars will be extracted, and the maxillary dental arch will be leveled and aligned upto 0.019 * 0.025-in stainless steel arch wire engaged in 0.022 * 0.028-in slot brackets. The maxillary second molars may be included in the arch wire and colligated to the maxillary second premolar and first molar with a 0.010-in stainless steel wire on each side that served as anchorage. The bilateral first molars are used for anchorage reinforcement. All individual canine retraction will be done by sliding mechanics using round stainless-steel wire (0.018 inch)

•       The canine will be segmented first, and the tooth length will be easily measured by using the 3-dimensional (3D) length measuring function in idixel software. The tooth length will be defined as the distance between crown tip and root tip.  The length reduction measured from the pretreatment and posttreatment scans will be used to quantify EARR

•        

 SCORING CRITERIA:

Grade

Defintion

Grade 0

No evidence of Root Resorption

Grade 1

Irregular Root Contour

Grade 2

Apical Root Resorption Less than 2mm

Grade 3

Apical Root Resorption >2mm and <13rd of its original length

Grade 4

Root Resorption exceeding 1/3rd of its original length

Grade

Defintion


 
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