CTRI Number |
CTRI/2023/06/054445 [Registered on: 26/06/2023] Trial Registered Prospectively |
Last Modified On: |
22/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two dental injection techniques in terms of pain perception in children during dental treatment |
Scientific Title of Study
|
Comparison of pain perception during administration of local anesthesia with jet injector and conventional injection technique using Wong- Baker scale in 6-12 years old children – a randomized controlled trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Manali Khole |
Designation |
Post graduate student |
Affiliation |
Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur |
Address |
Second floor,202, Department of pediatric and preventive dentistry, Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur, Maharashtra 441110, India.
Nagpur MAHARASHTRA 441110 India |
Phone |
8149332558 |
Fax |
|
Email |
manalikhole1@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pankaj Chavhan |
Designation |
Reader and pg guide |
Affiliation |
Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur |
Address |
Second floor,202, Department of pediatric and preventive dentistry, Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur, Maharashtra 441110, India.
Nagpur MAHARASHTRA 441110 India |
Phone |
9923106330 |
Fax |
|
Email |
drpankajchavhan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manali Khole |
Designation |
Post graduate student |
Affiliation |
Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur |
Address |
Second floor,202, Department of pediatric and preventive dentistry, Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur, Maharashtra 441110, India.
Nagpur MAHARASHTRA 441110 India |
Phone |
8149332558 |
Fax |
|
Email |
manalikhole1@gmail.com |
|
Source of Monetary or Material Support
|
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur,
Maharashtra |
|
Primary Sponsor
|
Name |
Dr Manali Khole |
Address |
Second floor, 202, Department of pediatric and preventive dentistry,Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur,
Maharashtra |
Type of Sponsor |
Other [[self]] |
|
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 Manali Khole |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Second floor, 202, Swargiya
Dadasaheb Kalmegh
Smruti Dental College
and Hospital , Hingna,
Nagpur, Maharashtra, 441110, India Nagpur MAHARASHTRA |
8149332558
manalikhole1@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Conventional injection method |
The injection site will be cleaned and prepared with sterile dry gauze and a small quantity of topical anesthetic will be kept in place for at least 1 min.0.6ml will be used for buccal infiltration and for palatal 0.2ml will be used.Palatal infiltration will be given first. Then Pain perception will be recorded using Wong Baker Scale. After each infiltration Wong- Baker reading will be recorded and mean will be calculated for buccal and palatal infiltration.The Pulse Rate will be calculated with pulse oximeter before administration of Local anesthesia (pre induction) and also after administration of Local anesthesia (post induction). The injection will be used once for palatal infiltration on one side for each patient. |
Intervention |
Jet Injector System |
The injection site will be cleaned and prepared with sterile dry gauze and a small quantity of topical anesthetic will be kept in place for at least 1 min. 0.5 cc will be used for buccal infiltration and for palatal 0.2cc will be used. Palatal infiltration will be given first. Then Pain perception will be recorded using Wong Baker Scale. After each infiltration Wong- Baker reading will be recorded and mean will be calculated for buccal and palatal infiltration.The Pulse Rate will be calculated with pulse oximeter before administration of Local anesthesia (pre induction) and also after administration of Local anesthesia (post induction). |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
Aged between 6 -12 years requiring bilateral maxillary local anesthesia.
Having sufficient mouth opening.
Operation only on primary teeth decayed teeth that require anesthesia.
No history of previous administration of anesthesia.
ASA I category will be selected.
|
|
ExclusionCriteria |
Details |
Medically compromised patient.
Dental phobia.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Primary outcome is to assess Pain perception using Wong- Baker scale. |
Specific time at which the outcome will be assessed/estimated i.e. at baseline single intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
The secondary outcome is to measure pulse rate. |
Specific time at which the outcome will be assessed/estimated i.e. before & after intervention. |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
02/07/2023 |
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="1" Months="6" 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
|
Needle-related
pain (NRP)/ Blenophobia occurs most frequently during anesthesia in dentistry.
In children, the pain from NRPs can produce an emotional and negative cognitive
response towards the procedure. Pain has
long been associated with dentistry and has an
unusual relation and is the main reason that leads the patient to seek dental treatment.
In addition, dental fear and anxiety are the main causes that may lead
patients to bypass dental appointments. Fear-related behaviors have long been
recognized as the most serious aspect of patient management and can be an
impediment to dental care. For invasive
procedures, pain control is achieved typically by means of injection of local
anesthesia. Although this method is highly effective, it is also the dental
procedure that is most often associated with anxiety and negative responses.
For some patients, the injection itself is painful, and thus the procedure that
is designed to reduce pain may itself result in fear and procrastination. In addition,
patients often experience more fear at the sight of a needle during the
administration of local anesthetic than from the treatment itself. Therefore,
dentists have attempted to minimize the intensity of NRP associated with any
dental problem. The objective fear of the
child during administration of local
anesthesia ranges from sight of the needle to the pain that might be associated
with needle injection, which increases the anxiety of the patient resulting in
fear of receiving local anesthesia in the future. Thus,
there is a need for attempting use of several methods to minimize pain during
administering local anesthesia. Jet-injector
are needle-free systems that work with the principle of applying anesthetic
solution with pressure to penetrate the tissues with spring-loaded devices, in
a manner reinforced with pressurized air or gas. To the best of our knowledge, limited
literature is available on the pain perception of the jet injectors on
pediatric population. In this study, we aimed to compare the pain perception of
jet injector method and conventional injection method in a pediatric population
of age 6-12 years.
Primary Objectives: To
compare the effect of the jet injection and conventional injection method on
pain perception in children 6-12 years of age using Wong- Baker scale. Methodology: Children
coming in the department of pedodontics and preventive dentistry will be
included in study and requiring administration of local anesthesia on both sides of maxilla will be included in
study for various procedures. Based
on inclusion criteria, 50 children of age group 6- 12 years will be selected
for study. Both the genders will have equal opportunity to
participate in the study.
Each child will be assigned for both the jet injector and conventional
injection technique. Method to be administered first will be decided
alternately and the side determination will be done by flip the coin technique.
|