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CTRI Number  CTRI/2024/07/071298 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARISON OF ICE WITH NUMBING AGENT TO COMPARE THE EFFECTS OF PAIN ON INJECTION IN MOUTH  
Scientific Title of Study   COMPARISON OF TOPICAL APPLICATION OF ICE VERSUS 2PERCENT LIGNOCAINE GEL IN REDUCING ORAL MUCOSAL INJECTION PAIN A SPLIT MOUTH STUDY  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sweta V Giddappanavar 
Designation  Pg student  
Affiliation  KVG Dental college and hospital, Sullia 
Address  KVG dental college and hospital Department of oral and maxillofacial surgery Room no.2 Kurunjibagh Sullia, Dakshina Kannada KARNATAKA 574327 INDIA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9611370860  
Fax    
Email  shwetavg886@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachana P B 
Designation  professor 
Affiliation  KVG Dental college and hospital, Sullia 
Address  KVG dental college and hospital Department of oral and maxillofacial surgery Room no.2 Kurunjibagh Sullia, Dakshina Kannada KARNATAKA 574327 INDIA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9686715342  
Fax    
Email  rachanadeepthi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sweta V Giddappanavar 
Designation  Pg student 
Affiliation  KVG Dental college and hospital, Sullia 
Address  KVG dental college and hospital Department of oral and maxillofacial surgery Room no.2 Kurunjibagh Sullia, Dakshina Kannada KARNATAKA 574327 INDIA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9611370860  
Fax    
Email  shwetavg886@gmail.com  
 
Source of Monetary or Material Support  
Department of oral and maxillofacial surgery room no.2 KVG dental college and hospital Kurunjibagh Sullia Dakshina kannada 574327 
 
Primary Sponsor  
Name  KVG dental college and hospital, Sullia 
Address  Kvg dental college and hospital,kurunjibhag, sullia, dakshina kannada 
Type of Sponsor  Other [Private dental college 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 
Dr Sweta V Giddappanavar  KVG dental college and hospital  Department of oral and maxillofacial surgery Roomno.2 Kurunjibagh Sullia, Dakshina Kannada KARNATAKA 574327 INDIA
Dakshina Kannada
KARNATAKA 		 9611370860

shwetavg886@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethics committee KVG Dental College and hospital Sullia 574327  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K119||Disease of salivary gland, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: K118||Other diseases of salivary glands,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% lignocaine gel  application of 2% lignocaine gel for 1.5 minutes 
Intervention  ICE  Application of ICE for 1.5 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  -Patients who are willing to participate in the study.
-Patients indicated for bilateral maxillary premolar teeth extraction.
-Male and female patients of age 18-30 years.-Individuals under ASA I and II. 
 
ExclusionCriteria 
Details  -Reported allergy or hypersensitivity to sulphites, amide type local anesthetics, ingredients in
anesthetic solution or any of the products used in the study.
-Patients with severe acute infections.
-Patients with gross periapical pathology.
-Patients having a habit of smoking and consuming alcohol.
-Women who are pregnant.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficiency of topical ice application and 2% lignocaine gel in reducing oral
mucosal pain 		 heart rate pre op and post op
1.5mins after ice and LA gel application- VAS scale
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the pain during buccal palatal injection after ice application based on Visual
Analogue Scale.
2. To assess the pain during buccal palatal injection after topical 2% lignocaine gel application
based on Visual Analogue Scale
3. To assess the heart rate during buccal palatal injection after ice application based on Digital
pulse oximeter.
4. To assess the heart rate during buccal palatal injection after topical 2% lignocaine gel
application based on Digital pulse oximeter.
5. To compare evaluate the pain between the two.
6. To compare evaluate the heart rate between the two.
7. To assess the patients compliance with ice topical anaesthesia. 		 heart rate pre op post op
1.5mins after ice LA gel application VAS scale 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/08/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study aims to compare the efficacy of topical ice application versus 2% lignocaine gel in reducing oral mucosal pain during buccal and palatal injections for bilateral extraction of maxillary premolars. The primary objective is to evaluate pain intensity using the Visual Analogue Scale (VAS) after each method of anesthesia administration. Additionally, heart rate changes during injections will be assessed using a digital pulse oximeter. The study hypothesizes that topical ice is as effective as lignocaine gel in reducing injection pain.

Twenty patients aged 18-30 years, meeting inclusion criteria and without exclusion criteria, will participate in this randomized controlled split-mouth clinical trial at KVG Dental College & Hospital. Each patient will receive both forms of anesthesia (ice application and lignocaine gel) during separate extraction sessions, randomly assigned to either side of the mouth.

Procedure involves topical anesthesia application using standardized techniques. Pain assessment will be immediate post-injection using the VAS, where a score of 0 indicates no pain and 10 indicates severe pain. Heart rate variations will be monitored throughout the procedure.

This study contributes to understanding the comparative effectiveness of topical ice versus lignocaine gel in dental anesthesia, potentially influencing clinical practice guidelines to optimize patient comfort and procedural outcomes.

 
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