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CTRI Number  CTRI/2023/05/052211 [Registered on: 02/05/2023] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARAING THE SPEED OF TOOTH MOVEMENT IN TWO TYPES OF FASTEN TOOTH MOVEMENTS. 
Scientific Title of Study   COMPARATIVE EVALUATION BETWEEN PLATELET RICH PLASMA (PRP) AND PIEZOCISION ASSISTED RATE OF RETRACTION IN BIMAXILLARY PROTRUSION CASES - A CLINICAL 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 POOJA SHARMA 
Designation  POST GRADUATE STUDENT  
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES  
Address  ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET

Kodagu
KARNATAKA
571218
India 
Phone  9008601770  
Fax    
Email  pooja1stapril@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR GOUTHAM B 
Designation  PROFESSOR AND HOD  
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES  
Address  ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET

Kodagu
KARNATAKA
571218
India 
Phone  9900620536  
Fax    
Email  drgouthamreddy2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GOUTHAM B 
Designation  PROFESSOR AND HOD  
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES  
Address  ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET

Kodagu
KARNATAKA
571218
India 
Phone  9900620536  
Fax    
Email  drgouthamreddy2000@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR POOJA SHARMA 
Address  ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET  
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 POOJA SHARMA  COORG INSTITUTE OF DENTAL SCIENCES   ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET
Kodagu
KARNATAKA 
9008601770

pooja1stapril@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
COORG INSTITUTE OF DENTAL SCIENCES   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  RATE OF RETARCTION IN PRP  In group B retraction will be carried out with submucosal injection of PRP on experimental side and without PRP on the control side. 
Comparator Agent  RATE OF RETRACTION IN CONTROL   In both group A and B control side retraction will be done without any intervention 
Intervention  RATE OF RETRACTION IN PIEZOCISION   In group A retraction will be started with piezocision on experimental and without piezocision on control side  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Angle’s class I malocclusion indicated for bilateral maxillary first premolar extraction.
2.Male and female patients between the age group of 18 and 45 years.
3.Patients with no clinical signs of periodontal diseases.
4.Patients with no gingivitis or untreated caries
5.Patients with no history of periodontal therapy.
 
 
ExclusionCriteria 
Details  1.Previous history of any orthodontic or orthopedic treatment
2.Any bone pathology, ankylosed teeth.
3.Patients taking drugs modifying normal bone physiology (i.e., bisphosphonates) on or before a period of 3 months.
4.Long term use of anti-biotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids and calcium channel blockers.
5.Smokers
6.Patients with evidence of bone loss.
7.Patient having a pacemaker or any other active implant.
8.Patients who have undergone periodontal treatment within three months of baseline examination.
9.Systemic disorder that could influence periodontal health.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•To assess the rate of enmasse retraction with Piezocision induced accelerated orthodontic tooth movement in bimaxillary protrusion cases.
•To assess the rate of enmasse retraction with Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement in bimaxillary protrusion cases.
 
T0 - Beginning of enmasse retraction
T1 - After 90 days of enmasse retraction.
 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the rate of enmasse retraction between Piezocision induced and Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement in bimaxillary protrusion cases.  T0 - Beginning of enmasse retraction
T1 - After 90 days of enmasse retraction.
 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   05/06/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The long duration of orthodontic treatment is one of the most frequent complaints of orthodontic patients. It results from the use of traditional mechanical forces to induce movement by stimulation of resorption modelling in the paradental tissue (1). Long term orthodontic treatment causes increase in the risk of dental caries, gingival recession and root resorption. Shorter duration of orthodontic treatment is the need of the hour in current practice as huge number of adult patients demand results within a short span of time. As a result, there is an increased number of studies focusing on methods that accelerate orthodontic tooth movement.

Several noninvasive or invasive techniques have been proposed clinically or experimentally for accelerating orthodontic tooth movement (2). The noninvasive techniques include (a) biomechanical approach such as the self-ligation brackets (b) physiological approach such as the direct electric current stimulation, the low-level laser therapy, vibration or photo modulation and (c) pharmacological approach such as the injection of prostaglandin or relaxin (3).

Keser and Dibart, introduced the Piezocision technique, a novel minimally invasive technique for accelerated tooth movement (4). One of the recently used local agents to accelerate the rate of orthodontic tooth movement is platelet-rich plasma (PRP). PRP is defined as an autologous concentration of platelets in a minute volume of plasma.

Through this study, we will be assessing and comparing the rate of enmasse retraction between Piezocision and Platelet-rich plasma (PRP) induced accelerated tooth movement in bimaxillary protrusion cases.

 
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