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CTRI Number  CTRI/2019/08/020545 [Registered on: 05/08/2019] Trial Registered Prospectively
Last Modified On: 03/08/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Use of a smaller needle or topical ice for reducing pain during local anesthesia in dental treatment 
Scientific Title of Study   Effectiveness of using a smaller needle or topical ice pressure application for pain reduction during administration of local anesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srikanth Gadicherla 
Designation  Professor and Head of the Department 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room number 4, Department of Oral and Maxillofacial surgery, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  gadi_mds@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Srikanth Gadicherla 
Designation  Professor and Head of the Department 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room number 4, Department of Oral and Maxillofacial surgery, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  gadi_mds@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Srikanth Gadicherla 
Designation  Professor and Head of the Department 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room number 4, Department of Oral and Maxillofacial surgery, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  gadi_mds@rediffmail.com  
 
Source of Monetary or Material Support  
Madhava Nagar, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal 576104, Udupi, Karnataka, India 
 
Primary Sponsor  
Name  Manipal College of Dental Sciences Manipal 
Address  Madhav Nagar, Manipal, Udupi, Karnataka 
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 
Gadicherla Srikanth  Manipal College of Dental Sciences, Manipal  Room number 4, Department of Oral Surgery, Manipal College of Dental Sciences, Manipal, Madhav nagar, Manipal
Udupi
KARNATAKA 
9986455201

gadi_mds@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin syringe Local anesthesia technique  Insulin syringe - 30 gauge, 12mm needle is used to administer buccal infiltration of local anesthetic solution 
Comparator Agent  Normal Local anesthesia technique  Normal syringe - 26 gauge, 1/2 inch needle is used to administer buccal infiltration of local anesthetic solution 
Comparator Agent  Palatal infiltration - Insulin needle   Insulin syringe - 30 gauge, 12mm needle is used to administer palatal infiltration of local anesthetic solution 
Intervention  Palatal infiltration - Insulin needle with Ice pressure  An iced cotton bud is placed at the proposed injection site for 1 minute. Insulin syringe - 30 gauge, 12mm needle is used to administer palatal infiltration of local anesthetic solution 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Includes healthy patients requiring bilateral maxillary first or second premolar extractions. 
 
ExclusionCriteria 
Details  Excludes patients with diabetes, bleeding disorders, handicap, chronic pain conditions, any periapical pathology, who need premedication, nitrous oxide/oxygen sedation,
emergency cases, uncooperative patients, exceedingly anxious and those with any
history suggestive of being medically compromised 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective evaluation of pain is done 5 mins after each injection by Visual Analog Scale
(VAS) by patient. Score 0 implies no pain or discomfort and Score 10 implies maximum pain or
discomfort.
Objective evaluation such as tingling sensation and numbness is evaluated after 5 mins. 
Subjective evaluation of pain - 5 mins after injection.
Objective evaluation - 5 mins after injection.  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   10/08/2019 
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="0"
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  
The primary cause of fear of dentists is the pain associated with dental treatment for which dental surgeons administer local anaesthetics. Local anesthesia (LA) acts by diffusing into the nerve membrane and blocking voltage gated sodium channels. However, the very process of administering LA is perceived as painful. The prick of the needle initiates a sharp acute pain while the infiltration of the LA fluid results in a dull and prolonged pain due to rapid distension of the tissue spaces and chemical irritation to the local nerve. The use of an insulin needle to inject the LA will trigger less nociceptors when compared to a regular 26G needle due to its finer diameter resulting in a significant reduction in pain perception. Also, employing a pre-anesthetic tool such as iced cotton swabs causes a temporary drop in tissue temperature at the site of injection. The cold temperatures temporarily reduce cellular metabolic rates, decrease the free nerve ending sensitivity, increase nerve firing threshold and slow down synaptic activity. It also slows down the blood flow and reduces inflammation. Furthermore, topical ice pressure application will reduce tissue expansion. All these factors will help in effective pain reduction during an LA injection.
A total of 70 patients requiring bilateral maxillary first or second premolar extractions are selected for the split-mouth study. A detailed case history is taken for each patient. A fresh pack of sterile cotton buds is dipped in clean water and freezed.
The dimensions of the syringes used are as follows:-
Normal syringe - 26 gauge, 1/2 inch needle and Insulin syringe - 30 gauge , 12mm needle
A fresh needle is used for every puncture.
Local anaesthetic - 2% lidocaine, 1: 200,000 adrenaline and Topical lignocaine gel.
1) To evaluate the effectiveness of using a finer needle over a normal thickness needle
A. Left buccal infiltration – Normal needle (routinely used)
B. Right buccal infiltration - Insulin needle (experimental)
2) To evaluate the effectiveness of topical ice pressure application
A. Left palatal infiltration - Insulin needle (not routinely used but for comfort of patient)
B. Right palatal infiltration - Insulin needle + Iced cotton bud. (experimental)
 
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