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CTRI Number  CTRI/2024/12/078736 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of local anesthesia onset and duration based on temperature and pharmacological agents 
Scientific Title of Study   Comparative evaluation of the efficacy of supplemental local anesthesia using temperature variation along with pharmacological agents for irreversible pulpitis: a randomized controlled trial 
Trial Acronym  LA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aakash Gupta 
Designation  Senior Resident 
Affiliation  AIIMS, Bathinda 
Address  Room Number 3028, C-block, Ground floor, Department of Dentistry; AIIMS, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9877939523  
Fax    
Email  guptaaakash95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tarun Kumar Singh 
Designation  Associate Professor 
Affiliation  AIIMS, Bathinda 
Address  Room Number 3027, C-block, Ground floor, Department of Dentistry; AIIMS, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9560627466  
Fax    
Email  drtarunkumarsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aakash Gupta 
Designation  Senior Resident 
Affiliation  AIIMS, Bathinda 
Address  Division of Conservative Dentistry and Endodontics, Department of Dentistry, AIIMS, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9877939523  
Fax    
Email  guptaaakash95@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda (Punjab), India-151001 
 
Primary Sponsor  
Name  Aakash Gupta 
Address  Room Number 3028, Ground Floor, C-Block, AIIMS; Bathinda 
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 Aakash Gupta  AIIMS Bathinda  Room Number 3028, Division of Conservative Dentistry and Endodontics, Department of Dentistry
Bathinda
PUNJAB 		 09877939523

guptaaakash95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1ml of warm 2%lignocaine  check the onset and duration of supplemental local infiltration along with main nerve block 
Intervention  1ml of cold 2% lignocaine with 1:200000 adrenaline  check the onset and duration of supplemental local infiltration along with main nerve block 
Intervention  1ml of Dexamethasone  check the onset and duration of supplemental local infiltration along with main nerve block 
Intervention  1ml of tramadol  check the onset and duration of supplemental local infiltration along with main nerve block 
Comparator Agent  2%lignocaine with 1:200000 adrenaline as supplemental anesthesia  Main nerve block of 1.8ml 2%lignocaine with 1:200000 adrenaline with supplemental local infiltration of 2%lignocaine with 1:200000 adrenaline to check onset and duration of anesthesia 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Teeth with symptomatic irreversible pulpitis
Teeth with normal tooth anatomy
Class I or II medical history (American Society of Anesthesiologists)
 
 
ExclusionCriteria 
Details  Allergic to local anesthesia
Periodontally compromised teeth.
Teeth with vertical fracture
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
effect of various agents as supplemental anesthesia on onset and duration of anesthesia for patients with symptomatic irreversible pulpitis  3 minutes after injection local infiltration before starting treatment and during the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
any associated side effect  duration of supplemental local anesthesia 
patient pain levels assessed before & after the procedure using numeric pain rating scale  pain rating scale before & after the completion of procedure 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/01/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  10/01/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="25" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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 is a randomized, double blind, parallel group, multi-center trial comparing the efficacy of various pharmacological agents such as 1ml/4mg of dexamethasone, 1 mL/30 mg of ketorolac tromethamine, 1ml/50mg of tramadol when used as a supplemental local anesthetic agent along with temperature variation of local anesthesia (2% lignocaine with 1:200000 adrenaline) at different temperature such as cold LA at 4degree celsius and warm LA at 37 degree celsius used for supplemental buccal infiltration along with conventional inferior alveolar nerve block(2% lignocaine with 1:200000 adrenaline).  Pain Numerical scale is used for noting the response obtained from patients. 
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