| 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
|
|
|
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
|
|
|
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. |