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CTRI Number  CTRI/2018/03/012834 [Registered on: 26/03/2018] Trial Registered Prospectively
Last Modified On: 02/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessing the effectiveness of cold local anesthesia in management of acute tooth pain 
Scientific Title of Study   Evaluation of pain on injection, onset and anesthetic efficacy of precooled injection site and 2% lignocaine (4-6ºC) during maxillary infiltration in patients with symptomatic irreversible pulpitis - a randomized controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ishwarya Gurucharan 
Designation  Post graduate student 
Affiliation  SRM Dental College, Ramapuram 
Address  Main block, 2nd floor, Department of conservative dentistry and endodontics, SRM dental college, Ramapuram, Bharathi Salai, Chennai.
Main block, 2nd floor, Department of conservative dentistry and endodontics, SRM dental college, Ramapuram, Bharathi Salai, Chennai.
Chennai
TAMIL NADU
600089
India 
Phone  9840377323  
Fax  04422490009  
Email  sriish@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sekar Mahalaxmi 
Designation  MDS, Professor and Head 
Affiliation  SRM Dental College, Ramapuram 
Address  Main block, 2nd floor, Department of conservative dentistry and endodontics, SRM dental college, Ramapuram, Bharathi Salai, Chennai.
Main block, 2nd floor, Department of conservative dentistry and endodontics, SRM dental college, Ramapuram, Bharathi Salai, Chennai.
Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax  04422490009  
Email  researchmaha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sekar Mahalaxmi 
Designation  MDS, Professor and Head 
Affiliation  SRM Dental College, Ramapuram 
Address  Main block, 2nd floor, Department of conservative dentistry and endodontics, SRM dental college, Ramapuram, Bharathi Salai, Chennai.
Main block, 2nd floor, Department of conservative dentistry and endodontics, SRM dental college, Ramapuram, Bharathi Salai, Chennai.
Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax  04422490009  
Email  researchmaha@gmail.com  
 
Source of Monetary or Material Support  
Ishwarya Gurucharan 
 
Primary Sponsor  
Name  Ishwarya Gurucharan 
Address  SRM Dental College, Barathi Salai, Ramapuram, Chennai 
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 
Ishwarya Gurucharan  SRM dental college  Main block, second floor, Department of conservative dentistry and endodontics, Bharathi Salai, Ramapuram, Chennai
Chennai
TAMIL NADU 
9840377323

sriish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, SRM dental College, Ramapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  ASA Category 1 
Patients  Symptomatic irreversible pulpitis, Hot tooth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  8-10 degrees celcius cold lignocaine   Ice sticks will be used for surface anesthesia 
Comparator Agent  Room temperature lignocaine  Topical local anesthesia gel will be used for surface anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Healthy adult patients aged 18 to 45 years who are willing to give informed consent
Teeth with acute and spontaneous pain
Patients with symptomatic irreversible pulpitis in maxillary molars of both the quadrants
Presence of vital tissue on access opening 
 
ExclusionCriteria 
Details  Allergic to Local anesthetics
Medically compromised patients (ASA Class III or higher)
Patients under medication which may affect the pain assessment
Inability to give informed consent
Teeth with
presence of Periapical radiolucencies
presence of active pathosis in the injection site
vertical fractures
periodontally compromised teeth
nonrestorable teeth 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduced pain on injection
Faster onset of pulpal anesthesia 
Onset - 1 minute after injection of anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
Greater anesthetic efficacy  15 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/04/2018 
Date of Study Completion (India) 15/02/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Achieving profound pulpal anesthesia in endodontics is a challenging task, particularly, in cases of acutely inflamed teeth. When conventional primary anesthetic techniques fail, there might be a need for a supplemental anesthesia. Local anesthetic(LA) administration may also add to patient’s discomfort. Cold application to a localized area to block the pain impulses is referred to as “Cryoanesthesia”, which is widely practiced in the field of medicine. One of the strategies to reduce pain perception during local anesthetic administration is precooling the injection site, as stated by Ghaderi et al.(2013) Further, use of cooled anesthetic solution to enhance pulpal anesthesia is attributed to an increase in affinity of the charged anesthetic molecule to nerve receptors. However, the effect of refrigerated 2% lignocaine HCl for maxillary infiltration anesthesia in molars has not been evaluated yet. Hence, the aim of the present study is to assess the effects of precooling the injection site and administration of cold 2% lignocaine HCl (8-10oC) in symptomatic irreversible pulpitis of maxillary molars and also to compare the pain on injection, onset of action and anesthetic efficacy achieved with that of 2% lignocaine HCl (room temperature), with and without precooling the injection site. The experimental groups are:

Group 1: Precooling the injection site and cold 2% lignocaine HCl.

Group 2: LA gel with 2% lignocaine HCl (room temperature)

Pain score will be assessed using Heft Parker scale (VAS) and other parameters will be assessed using EPT.

 
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