| 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
|
|
|
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
|
|
|
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. |