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
|
|
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
|
|
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 “transmissionâ€
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 . |