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
|
|
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
|
|
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) |