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CTRI Number  CTRI/2024/07/070006 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the new PRP loop with Opus loop for closing extraction space 
Scientific Title of Study   Comparative Evaluation of Efficacy of the Novel PRP Loop with Opus Loop for Anterior EnMasse Retraction in Angles Class I Deweys Type 2 Malocclusion A Single Blinded Randomized Clinical Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krushnali Kolhatkar 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  102,1st floor,Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  08308766596  
Fax    
Email  drkrushnalimds@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Niranjane 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  102,1st floor, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9823449728  
Fax    
Email  drpriyankaniranjane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krushnali Kolhatkar 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8308766596  
Fax    
Email  drkrushnalimds@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi Meghe Wardha India 442001 
Type of Sponsor  Private medical college 
 
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 Krushnali Kolhatkar  Sharad Pawar Dental College and Hospital  Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, 442001
Wardha
MAHARASHTRA 
08308766596

drkrushnalimds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K002||Abnormalities of size and form ofteeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Opus Loop  Opus loop will be randomly allocated in Group B and observed from the start , after 2 months, 4 months till anterior en-masse retraction is completed. 
Intervention  PRP Loop  PRP loop will be randomly allocated in Group A and observed from the start , after 2 months, 4 months till anterior en-masse retraction is completed 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Age- 15 to 30 years patients with Angle’s Class I Dewey’s type 2 malocclusion.
Patients having average growth pattern requiring maxillary premolar extractions.
Moderate to critical anchorage cases.
Those with healthy periodontal status, without periodontal pocket depths more than 2 to 3 mm and the ones who require fixed orthodontic treatment.
 
 
ExclusionCriteria 
Details  Those with Angle’s Class II and III malocclusion.
Patients having inborn and developmental syndromes.
Systemic disorders like clotting diseases or conditions such as pregnancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
PRP loop may be an effective tool for anterior en-masse retraction and may lead to minimum anchorage loss.
 
1st assessment- 2months
2nd assessment- after extraction space closure 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

Optimal space closure is a pivotal aspect of orthodontic treatment, particularly challenging in patients with bimaxillary protrusions and Angle’s Class II Division 1 malocclusion. Two primary methods, friction and frictionless mechanisms, are employed for anterior teeth retraction. However, concerns over prolonged treatment duration and increased anchorage demands have prompted exploration into non-frictional approaches. Biomechanical properties significantly influence the efficacy of retraction loops, with ideal loops exhibiting high moment-to-force (M/F) ratios and low force-to-deflection (F/D) ratios. Inspired by existing designs, the "PRP loop" was developed, showing promising biomechanical characteristics in a finite element study. However, its clinical efficacy remains unexplored. This study aims to evaluate and compare the PRP loop with the Opus loop for anterior en-masse retraction in Angle’s Class I Dewey’s Type 2 malocclusion.

Literature review reveals studies highlighting the importance of loop design on tooth movement efficiency and anchorage preservation. Methodology involves a prospective, single-blinded randomized clinical trial with 30 patients divided into PRP and Opus loop groups. Treatment procedures include initial alignment, maxillary premolar extractions, and retraction using respective loops. Evaluation criteria encompass retraction rate, efficacy, and anchorage loss measured through clinical and radiographic assessments.

Statistical analysis will employ Student’s t-test with GraphPad Prism 7.0 and SPSS 27.0 software. Results will contribute to understanding the clinical effectiveness of the PRP loop compared to the Opus loop, providing valuable insights into optimizing space closure techniques in orthodontic practice.

 
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