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CTRI Number  CTRI/2026/04/109203 [Registered on: 23/04/2026] Trial Registered Prospectively
Last Modified On: 21/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Does using chilled numbing medicine reduce injection pain, increase the speed of numbness and improve comfort for people with severe lower back toothaches. 
Scientific Title of Study   Comparative evaluation of the effect of pre-cooling two different anesthetic solutions on injection pain, anesthesia onset and anesthetic efficiency of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars – a double blind randomised control trial. 
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 Maria Jaison 
Designation  Post Graduate  
Affiliation  Royal Dental College, Department of conservative dentistry and endodontics, first floor, room number 4,Iron Hills, Chalissery, Palakkad Kerala  
Address  Royal Dental College, Department of conservative dentistry and endodontics, first floor, room number 4,Iron Hills, Chalissery, Palakkad Kerala

Palakkad
KERALA
679536
India 
Phone  9497187218  
Fax    
Email  mariajaison1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Biju P Babu 
Designation  Professor in department of conservative dentistry and endodontics 
Affiliation  Royal Dental College, Department of conservative dentistry and endodontics, first floor, room number 4,Iron Hills, Chalissery, Palakkad Kerala  
Address  Royal Dental College ,department of conservative dentistry and endodontics, first floor, room number 4,Iron Hills, Chalissery, Palakkad Kerala

Palakkad
KERALA
679536
India 
Phone  9539390000  
Fax    
Email  bijudent@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maria Jaison 
Designation  Post Graduate  
Affiliation  Royal Dental College, Department of conservative dentistry and endodontics ,first floor, room number 4 ,Iron Hills, Chalissery, Palakkad Kerala  
Address  Royal Dental College ,Department of conservative dentistry and endodontics ,first floor, room number 4 ,Iron Hills, Chalissery, Palakkad Kerala

Palakkad
KERALA
679536
India 
Phone  9497187218  
Fax    
Email  mariajaison1999@gmail.com  
 
Source of Monetary or Material Support  
Royal Dental College, Iron Hills Chalissery, Palakkad,679536,Kerala 
 
Primary Sponsor  
Name  Dr Maria Jaison 
Address  Royal Dental College, Iron Hills Chalissery, Palakkad,679536,Kerala 
Type of Sponsor  Other [Self] 
 
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 Maria Jaison  Royal Dental College  Department Of Conservative Dentistry And Endodontics, Room number 4, Iron Hills Chalissery, Palakkad,679536,Kerala
Palakkad
KERALA 
9497187218

mariajaison1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Royal Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Effect of pre-cooling two different anesthetic solutions on injection pain of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Articaine  1.8 ml of 4 percentage articaine with 1:1,00,000 epinephrine at room temperature administered in patients with symptomatic irreversible pulpitis in mandibular molars(Inferior alveolar nerve block).  
Intervention  Articaine  1.8 ml of 4 percentage articaine with 1:1,00,000 epinephrine pre-cooled to 4 degree celsius–6 degree celsius administered in patients with symptomatic irreversible pulpitis in mandibular molars(Inferior alveolar nerve block). 
Comparator Agent  Lignocaine  1.8 ml of 2 percentage lignocaine with 1:1,00,000 epinephrine at room temperature administered in patients with symptomatic irreversible pulpitis in mandibular molars(Inferior alveolar nerve block). 
Intervention  Lignocaine  1.8 ml of 2 percentage lignocaine with 1:1,00,000 epinephrine pre-cooled to 4 degree celsius–6 degree celsius administered in patients with symptomatic irreversible pulpitis in mandibular molars(Inferior alveolar nerve block)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Mandibular molars with symptomatic irreversible pulpitis
Absence of cardiac, hepatic and renal disorders
Willing to participate and engage in study
 
 
ExclusionCriteria 
Details  Absence of symptomatic irreversible pulpitis in mandibular molars.
Known hypersensitivity to lignocaine and articaine.
Patients with cardiac, hepatic and renal disorders.
Pregnant woman.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain on injection

 
Immediately following the injection (at the moment of needle withdrawal, on the same day of injection)

 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of anesthesia  Every minute after injection until two consecutive negative responses are obtained in a electric pulp tester(On the day of injection). 
Duration of anesthesia  Same day of the injection. 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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   Phase 4 
Date of First Enrollment (India)   12/05/2026 
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="8"
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 is a double blind randomised control trial to evaluate the clinical efficiency of two different anesthetic solutions, two percent lignocaine and four percent articaine, at two different temperatures. The temperatures compared will be room temperature and a cooled temperature ranging from four degrees Celsius to six degrees Celsius. The study focuses on patients diagnosed with symptomatic irreversible pulpitis in mandibular molars.

A standard inferior alveolar nerve block injection will be performed using a metallic aspirating dental syringe and a thirty gauge needle that is twenty-five millimetres long. A total volume of one point eight millilitres of the anesthetic solution will be injected slowly over a duration of sixty seconds.

Pain assessment will be conducted using a validated Heft-Parker Visual Analog Scale with a line length of one hundred and seventy millimetres. Patient pain perception will be recorded during the administration of the anesthesia and during the access cavity preparation. The onset of pulpal anesthesia will be monitored using an electric pulp tester every minute until two consecutive negative responses are obtained. Additionally, the duration of the anesthesia will be tracked by recording the time at which the effect completely wears off, either in the clinic or via a telephonic interview with the patient.

 
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