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CTRI Number  CTRI/2023/07/055648 [Registered on: 25/07/2023] Trial Registered Prospectively
Last Modified On: 23/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of cooled injection on injection pain and effectiveness for root canal treatment of painful lower back teeth 
Scientific Title of Study   Effect of precooling injection site and cold anesthetic administration on injection pain and anesthetic efficacy of inferior alveolar nerve block(IANB) in mandibular molars with symptomatic irreversible pulpitis - A randomised clinical 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  Sumaya changaranchola 
Designation  Junior resident ,Department of Conservative Dentistry and Endodontics 
Affiliation  Government Dental College Kottayam 
Address  Department of Conservative Dentistry and Endodontics, Government Dental College Kottayam.

Kottayam
KERALA
686008
India 
Phone  9995965474  
Fax    
Email  sumayacc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSheena P 
Designation  Associate Professor ,Department of Conservative Dentistry and Endodontics  
Affiliation  Government Dental College Kottayam 
Address  Department of Conservative Dentistry and Endodontics ,Government Dental College Kottayam

Kottayam
KERALA
686008
India 
Phone  9847632380  
Fax    
Email  sheenababu.p@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSheena P 
Designation  Associate Professor ,Department of Conservative Dentistry and Endodontics  
Affiliation  Government Dental College Kottayam 
Address  Department of Conservative Dentistry and Endodontics ,Government Dental College Kottayam

Kottayam
KERALA
686008
India 
Phone  9847632380  
Fax    
Email  sheenababu.p@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College Gandhinagar PO Kottayam Kerala Pin code 686008 
 
Primary Sponsor  
Name  Sumaya Changaranchola 
Address  Junior resident Department of Conservative Dentistry and Endodontics Government Dental College Kottayam 
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 sumaya changaranchola  Government dental college kottayam  Room number 404 Conservative Dentistry and Endodontics Government dental college kottayam Gandhinagar PO
Kottayam
KERALA 
9995965474

sumayacc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee(IEC)/Institutional Review Board(IRB) Government Dental College Kottayam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group I: lignocaine with epinephrine at room temperature (control)  Administering local anesthesia(lignocaine 2% with epinephrine 1:200000) at room temperature for inferior alveolar nerve block for root canal treatment of mandibular molars and assessment of pain on injection, onset of action of anesthesia and duration of action of anesthesia. Duration of intervention - one to two hours 
Intervention  Group II: lignocaine with epinephrine refrigerated (4-6degree Celsius)  Administering local anesthesia (lignocaine 2% with epinephrine 1:200000) refrigerated at 4-6degree Celsius for inferior alveolar nerve block for root canal treatment of mandibular molars and assessment of pain on injection ,onset of action of anesthesia and duration of action of anesthesia .intervention period is one to two hours 
Intervention  Group III: lignocaine with epinephrine refrigerated, topical ice application for 15 seconds at injection site.  Administering local anesthesia ((lignocaine 2% with epinephrine 1:200000 refrigerated at 4 to 6 degree Celsius and topical ice application for 15 seconds at injection site for inferior alveolar nerve block for root canal treatment of mandibular molars and assessment of pain on injection ,onset of action of anesthesia and duration of action of anesthesia. intervention period is one to two hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Healthy adult patients aged 18 to 50 years
Presence of irreversible pulpitis in a mandibular first molar, without any signs of periapical involvement.
Presence of healthy adjacent and contra-lateral second premolars 
 
ExclusionCriteria 
Details  Patients with known allergy, sensitivity or contraindication to lignocaine
Presence of systemic or mental disorders, pregnancy, lactation
Patients who had taken analgesics within 12 hours before root canal therapy
Presence of non-vital pulp tissue on access opening
Molars with calcified canals, pulp stones 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
pain on injection
 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of Anesthesia   At baseline
From onset of anesthesia (2 to 3 minutes after injection )
till wearing off anesthesia 
onset of anesthesia  At baseline
Time from administration of anesthesia to onset of action of anesthesia 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   01/08/2023 
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="1"
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  
An important requirement prior to initiating endodontic or operative dental treatment is the ability to achieve and maintain profound anesthesia. Local anesthetic solutions have been utilized in clinical dentistry to alleviate or eliminate pain associated with invasive procedures as early as the 19th century. An inferior alveolar nerve block (IANB)is the standardized injection technique for mandibular molar teeth. However, IANB does not always result in successful pulpal anesthesia, especially in patients with symptomatic irreversible pulpitis. The fact that patients often feel pain during endodontic treatment of teeth with symptomatic irreversible pulpitis is a challenge for the clinician. Successful anesthesia is only achieved if no or minimal pain is achieved during access cavity preparation and canal shaping.
Various different approaches have been tested to improve the success rate of IANBs in mandibular molars with symptomatic irreversible pulpitis. These include different anesthetic techniques for IANB, different anesthetic solutions, supplemental infiltration techniques, acupuncture, and premedication before the IANB is performed. Despite these approaches, the success rate of IANBs in mandibular molars with symptomatic irreversible pulpitis ranges from 15 -57 %.
It is a well-established physiological phenomenon that heat has the property of vasodilatation and cold has the property of vasoconstriction. Cold also has analgesic and anesthetic effects. In medicine, the application of a frozen gel pack for 5 min prior to Botulinum toxin A injection resulted in a statistically significant pain reduction. In the field of neuroscience, cooling of lignocaine was also found to have beneficial effects like faster onset of action and prolonged duration of action. Dabarakis et al showed that mepivacaine at a temperature of 4°C had a longer duration of pulpal anesthesia for the maxillary first premolar than at room temperature.
Some studies have been performed to evaluate the effect of cryotherapy and cooling of lignocaine on the injection pain and efficacy of maxillary infiltration and studies on cooled lignocaine injection of IANB. It is not known whether cooling of lignocaine hydrochloride and precooling injection site will have any beneficial effect, when used for inferior alveolar nerve block (IANB).
Hence, the purpose of this study was to evaluate the effects of cooling 2% lignocaine hydrochloride with 1:2,00,000 epinephrine along with precooling injection site on the primary outcomes of onset and duration of IANB. The secondary outcome to assess is pain on injection.
 
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