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CTRI Number  CTRI/2024/09/073219 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study done to reduce time of orthodontic treatment by comparing two methods 1)injecting -Injectable platelet rich fibrin (IPRF- derived from patients own blood ) and by piezocision( type of minimally invasive procedure) and checking levels of bone marker parameters in gingival fluid . 
Scientific Title of Study   Comparative evaluation of effect of IPRF and Piezocision on rate of orthodontic tooth movement and RANKL and OPG levels in GCF An in vivo 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  Dr Ratika Sawhney 
Designation  Post graduate student 
Affiliation  Inderprastha Dental College and Hospital  
Address  Department of Orthodontics and Dentofacial Orthopaedics ,third floor,room no 2,Inderprastha Dental College and Hospital ,46/1 ,Site IV Industrial Area ,Sahibabad . Ghaziabad (U.P)

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  8588866332  
Fax    
Email  Ratika_sawhney@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepti Yadav 
Designation  Professor 
Affiliation  Inderprastha Dental College and Hospital  
Address  Department of Orthodontics and Dentofacial Orthopaedics ,third floor,room no 2,Inderprastha Dental College and Hospital ,46/1 ,Site IV Industrial Area ,Sahibabad . Ghaziabad (U.P) INDIA

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9212794482  
Fax    
Email  deepti.yadav@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ratika Sawhney 
Designation  Post graduate student 
Affiliation  Inderprastha Dental College and Hospital  
Address  Department of Orthodontics and Dentofacial Orthopaedics ,third floor,room no 2,Inderprastha Dental College and Hospital ,46/1 ,Site IV Industrial Area ,Sahibabad . Ghaziabad (U.P)

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  8588866332  
Fax    
Email  Ratika_sawhney@yahoo.com  
 
Source of Monetary or Material Support  
Inderprastha Dental College & Hospital 46/1,Site IV Industrial Area ,Sahibabad,Ghaziabad (U.P)-201010,Delhi NCR ,UP,INDIA 
 
Primary Sponsor  
Name  Dr Ratika Sawhney 
Address  Department of Orthodontics and Dentofacial Orthopaedics ,third floor ,room number 2 ,Inderprastha Dental College & Hospital 46/1, Site IV, Industrial Area Sahibabad,Ghaziabad, Uttar Pradesh - 201010 
Type of Sponsor  Other [Dr Ratika Sawhney] 
 
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 Ratika Sawhney  Inderprastha Dental College & Hospital  Department of Orthodontics and Dentofacial Orthopaedics .Third floor ,room no 2.Inderprastrha Dental College and Hospital. 46/1, Site IV, Industrial Area Sahibabad, Ghaziabad, Uttar Pradesh - 201010
Ghaziabad
UTTAR PRADESH 		 8588866332

Ratika_sawhney@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Piezocision   Piezocision at experimental site at T0 baseline T1 after 2 weeks T2 after 4 weeks T3 after 6 weeks 
Intervention  IPRF -Injectable platelet rich fibrin.  Injection of IPRF On experimental site . Collection of GCF and measurement of tooth movement at -T0 baseline T1 after 2 weeks T2 after 4 weeks T3 after 6 weeks 
Comparator Agent  PIEZOCISION GROUP IPRF GROUP  Collection OF GCF and measurement of tooth movement in both the groups on control side at T0,T1,T2,T3 interval  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Aged 18 years or above.
- Patient requiring maxillary first Premolar extraction.
- Angle’s class I/ class II molar relationship.
- No history of orthodontic treatment.
- No systemic disease.
- No periodontal disease.
- Good oral hygiene
 
 
ExclusionCriteria 
Details  -Patients with Systemic diseases
-Patients taking medication that can interfere with orthodontic treatment.
- Poor oral hygiene.
-Periodontally compromised patients.
-Patients with parafunctional habits
-Angles’s class III molar relationship
-Extraction other than first premolar extraction in the maxillary arch
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
GCF samples will be collected from buccal and distobuccal sides of canine of experimental side and the control side, in both, 1-PRF and piezocision group.   baseline
2 weeks
4 weeks
6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/09/2024 
Date of Study Completion (India) 27/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Ratika_sawhney@yahoo.com].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 02-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - kindly provide email.
Brief Summary
Modification(s)  
 We are doing  this study to compare and evaluate the effect of IPRF and Piezocision on the rate of orthodontic tooth movement during en-masse retraction and levels of RANKL and OPG in gingival crevicular fluid ( GCF). 

OBJECTIVES OF THE STUDY WILL BE :
l)To clinically evaluate the effect of 1-PRF on rate of Orthodontic Tooth movement during en-masse retraction. 
2)To clinically evaluate the effect of piezocision technique on rate of orthodontic tooth movement during en-masse retraction. 
3) To compare the effects of 1-PRF and piezocision on rate of orthodontic tooth movement during en-masse retraction. 
4) To assess change in levels of RANKL and OPG in gingival crevicular fluid (GCF) during orthodontic tooth movement with IPRF and piezocision.(during en-masse retraction).

This will help us to evaluate efficacy of procedures like Injectable platelet rich fibrin and piezocision in making tooth movement faster in decreasing treatment time during orthodontic treatment .
 
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