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CTRI Number  CTRI/2020/04/024923 [Registered on: 29/04/2020] Trial Registered Prospectively
Last Modified On: 28/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Checking the painless efficacy of vibrating device attached to syringe in patients undergoing tooth removal with premolar on both the sides of upper jaw 
Scientific Title of Study   Evaluation of effectiveness of Vibraject injection technique in patients undergoing orthodontic extraction of bilateral maxillary premolar-A prospective split-mouth study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jui Shekhar Karmarkar 
Designation  2nd year MDS 
Affiliation  V.S.P.M Dental College and Research Center 
Address  Room no 2,Ground floor, Department of Oral and Maxillofacial Surgery,V.S.P.M D.C.R.C ,Hingna- Nagpur
V.S.P.M Dental College and Research Center,Police Nagar,Hingna,Nagpur.
Nagpur
MAHARASHTRA
440019
India 
Phone  7066620270  
Fax    
Email  juikarmarkar14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jui Shekhar Karmarkar 
Designation  2nd year MDS 
Affiliation  V.S.P.M Dental College and Research Center 
Address  Room no 2,Ground floor, Department of Oral and Maxillofacial Surgery,V.S.P.M.D.C.R.C, Nagpur.
V.S.P.M Dental College and Research Center,Police Nagar,Hingna,Nagpur.
Nagpur
MAHARASHTRA
440019
India 
Phone  7066620270  
Fax    
Email  juikarmarkar14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vrinda Sunil Kolte 
Designation  Prof. Of Department of oral and Maxillofacial Surgery 
Affiliation  V.S.P.M Dental College and Research Center 
Address  V.S.P.M Dental College and Research Center,Police Nagar,Hingna,Nagpur
V.S.P.M Dental College and Research Center,Police Nagar,Hingna,Nagpur.
Nagpur
MAHARASHTRA
440019
India 
Phone  9822366938  
Fax    
Email  drvrindkolte@gmail.com  
 
Source of Monetary or Material Support  
V.S.P.M Dental College and Research Center ,Nagpur. 
 
Primary Sponsor  
Name  Jui Shekhar Karmarkar 
Address  V.S.P.M Dental College and Research Center,Nagpur. 
Type of Sponsor  Research institution and hospital 
 
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 
Jui Karmarkar  V.S.P.M Dental college and Research Center  Room no 2,Ground floor, Department of Oral and Maxillofacial Surgery,Hingna road, digdoh hills ,police nagar Lata Mangeshkar Hospital
Nagpur
MAHARASHTRA 
7066620270

juikarmarkar14@gmail.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 
Healthy Human Volunteers  Orthodontic Extraction 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Injection Technique  Traditionally blocks delivered for anesthetizing maxillary premolar are Infra-orbital nerve block and Greater Palatine Nerve Block.Traditional technique of injection is painful especially Greater Palatine Nerve Block,whereas Vibraject device works on gate-control mechanism and helps in reducing pain during injection.  
Intervention  Vibraject Device  Vibraject is small vibrating device which has control knob at its back that helps in vibrations and it makes a ’hum’ sound along with vibrations. It is attached to conventional syringe with the help of clip brackets which are autoclavable which avoids cross contamination. Its mode of action is that, Vibraject causes vibrations once the control knob is rotated clockwise ,these vibrations are transferred to needle which mask the pain while needle insertion and solution deposition , moreover that it makes Humm sound which diverts patients mind .  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patient requiring bilateral maxillary premolar extractions for orthodontic purpose. 
 
ExclusionCriteria 
Details  Patients with known allergy to local anesthetic agent.
Mentally challenged patients.
patients with any systemic disease.
Patients not willing to give informed consent.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of vibraject injection technique while giving infra-orbital and greater palatine nerve block.   After acquiring all samples 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate Pain perception by Vibraject Injection technique while giving Infra-orbital and Greater palatine nerve block   During penetration of needle and during deposition of LA solution 
To evaluate Pain perception by Conventional Injection technique while giving Infra-orbital and Greater palatine nerve block  During needle penetration and during deposition of LA solution 
To compare pain perception between Vibraject Injection Technique and Conventional Injection Technique  after collection of all samples 
To evaluate effectiveness of anesthesia by assessing pain during extraction.  During extraction 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   01/05/2020 
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="10"
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)?  

Brief Summary  

Pain is the most common cause of dental anxiety,

Injecting effective local anesthesia is the most important pillar to alleviate pain.

In maxilla, palatal nerve blocks are most painful blocks as compare to infraorbital and posterior superior alveolar nerve blocks.

To overcome these pain of  injection many newer technologies have been developed like Accupal  and Dentalvibe .

These devices had certain disadvantages with respect to cost and portablility .

In order to overcome limitation newer device called vibraject was introduced for delivering local anesthesia.

Vibraject is small vibrating device which has control knob at its back that helps in vibrations and it makes a ’hum’ sound along with vibrations. It is attached to conventional syringe with the help of clip brackets which are autoclavable  which avoids cross contamination.

Its  mode of action is that,

vibraject causes vibrations once the control knob is rotated clockwise ,these vibrations are transferred to needle which mask the pain while needle insertion and solution deposition , moreover that it makes ’ Humm ’ sound which diverts patients mind .

 Its mechanism of action is based on Gate Control Theory,

In 1965, Ronald Melzack and Charles Patrick (Pat) Wall (Melzack and Wall 1965) proposed the Gate Control Theory of Pain.

There are nociceptors (pain fibers-small) and (touch,pressure and vibration) fibers-large ,  these fibers synapse in two different regions within the dorsal horn of the spinal cord: cells in the substantia gelatinosa and the “transmission” cells.

They proposed that the gate in the spinal cord is the substantia gelatinosa in the dorsal horn which modulates the transmission of sensory information from the primary afferent neurons to transmission cells in the spinal cord.

Large-fiber activity inhibits (or closes) the gate, whereas small-fiber activity facilitates (or opens) the gate.

This mechanism of action helps in alleviating pain .

 
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