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CTRI Number  CTRI/2022/07/044387 [Registered on: 27/07/2022] Trial Registered Prospectively
Last Modified On: 25/07/2022
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 Cold Local Anaesthesia for Root Canal Treatment 
Scientific Title of Study   Effect of Precooled Local Anaesthesia with and without Cryotherapy Application on Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis- A Randomized Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinoth kumar M 
Designation  I Year Post graduate Student  
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor, SRM Dental College Bharathi Salai, Ramapuram. Chennai TAMIL NADU 600089 India
SRM Dental College, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600089
India 
Phone  8870163263  
Fax  044-22492429   
Email  vinothlinn29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Mahalaxmi 
Designation  Professor and Head  
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor, SRM Dental College Bharathi Salai, Ramapuram. Chennai TAMIL NADU 600089 India
SRM Dental College, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax  044-22492429   
Email  researchmaha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B Saravana karthikeyan 
Designation  Professor  
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor, SRM Dental College Bharathi Salai, Ramapuram. Chennai TAMIL NADU 600089 India
SRM Dental College, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600089
India 
Phone  8939471176  
Fax  044-22492429   
Email  saravanb@srmist.edu.in  
 
Source of Monetary or Material Support  
Department of conservative and endodontics out patient department 2nd floor SRM Dental college Bharathi salai Ramapuram Chennai  
 
Primary Sponsor  
Name  SRM Dental College  
Address  Department of Conservative Dentistry and Endodontics (II nd floor) SRM Dental College Bharathi Salai, Ramapuram Chennai- 600 089, Tamil Nadu, India.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
na  n/a 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vinoth Kumar M  SRM Dental College and Hospital  Department of Conservative Dentistry and Endodontics out patient department 2nd floor Bharathi Salai Ramapuram Chennai TAMIL NADU
Chennai
TAMIL NADU 
8870163263
044-22492429
vinothlinn29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Local anaesthesia at room temperature  2ml of 2% lignocaine hydrochloride at the rate of 1ml /minute 
Intervention  Pre cooled Local anaesthesia  2ml of cold 2% lignocaine hydrochloride at the rate of 1ml /minute 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  48.00 Year(s)
Gender  Both 
Details  i) Male and female patients between the age group of 18-48 years.
ii) ASA class 1 or 2 patients.
iii) Preoperative pain scores ≥ 85 mm in HP-VAS scale
iv) Mandibular molars with an endodontic pulpal diagnosis of symptomatic irreversible pulpitis.
v) Patients who had not taken any analgesics the day before and the day of the root canal procedure.
 
 
ExclusionCriteria 
Details  i) Patients who refuse to give informed consent.
ii) Teeth other than mandibular molars (incisors, canines, premolars).
iii) Teeth with any resorptions, anatomy anomalies or perforations.
iv) Patients taking pain medication for other systemic conditions.
v) Allergic to local anesthetics or any other drugs.
vi) Conditions that influence the pain scores, and with presence of periapical radiolucency, swelling, and sinus tract.
vii) Teeth with vertical fractures and periodontally compromised teeth.
viii) Non-restorable teeth.
x) Patients with blood dyscrasias of unknown origin, cold intolerance, Raynaud’s disease, cold urticaria, cryoglobulinemia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the anaesthetic efficacy following IANB administration using precooled LA (4-6%)along with intraoral cryotherapy application in mandibular molars in symptomatic irreversible pulpitis patients.   Immediate 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the pain on injection and onset of anaesthesia following IANB administration using precooled LA (4-6%)along with intraoral cryotherapy application in mandibular molars in symptomatic irreversible pulpitis patients.   Immediate 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3 
Date of First Enrollment (India)   01/08/2022 
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="0"
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  

Inferior alveolar nerve block (IANB) using 2% lignocaine hydrochloride (HCl) with adrenaline in 1:100,000 (LA) concentration is considered to be one of the standard anaesthetic techniques for achieving pulpal anaesthesia for management of symptomatic irreversible pulpitis (SIP) in mandibular molars. However,  pulpal inflammation notably decreases the anaesthetic efficacy by eight-fold in SIP cases. It has been reported in literature that the anaesthetic failure rate in SIP patients vary between 15-57% in mandibular molars .  The reasons for such failures could be multi-factorial such as, decreased tissue pH, altered resting potentials, associated reduced thresholds in inflamed tissues, presence of tetrodotoxin-resistant (TTXr) sodium channels, lowered activation threshold of voltage gated sodium channels, activation of nociceptors, increase in pro-inflammatory cytokines in caries exposed pulps, in addition to the patient and operator related factors .

To overcome the difficulties and to improve the success of pulpal anaesthesia in SIP patients, various adjuvant methods are recommended which include, premedication with nonsteroidal anti-inflammatory drugs (NSAIDs), replacing lignocaine with articaine/bupivacaine/mepivacaine anesthetics and supplemental anaesthetic techniques such as, intraligamentary, intra-osseous and/ intra-pulpal anaesthesia. However, each supplementary technique/methods possess their own drawbacks. For instance, NSAIDs can increase the range of gastrointestinal problems and renal complications whereas replacement of lignocaine with other anesthetics like bupivacaine, mepivacaine or articaine results in anxiety, cardiotoxicity, blurred vision and gingival complications respectively. Intraligamentary method results in periodontal tissue damage and bacteremia whereas intra-osseous administration causes post injection discomfort and is a quite technique sensitive procedure. Further, intra-pulpal injections usually cause high patient discomfort.   

Cryotherapy is a long-standing therapeutic technique that has frequently been applied in medicine for pain management and postoperative care. More recently, it has been reported that intraoral cryotherapy application on the vestibular surface of the treated mandibular molar for 5 mins after IANB application enhanced the anaesthetic success rate in SIP patients. The basic physiological tissue effects of cryotherapy include vascular and neurologic changes. If tissue is exposed to reduced temperatures, an initial reflex vasoconstriction occurs and is followed by cold-induced vasodilatation. This process occurs as a neural reflex triggered by the adrenergic elements of the blood vessels and decreases vascular permeability, thereby reducing tissue inflammation.  Regarding the neurologic effect, cryotherapy induces analgesia by impeding the transmission of both A and C fibers. In addition, cold application might decrease the activation threshold of tissue nociceptors resulting in a local anaesthetic effect that is defined as cold induced neuropraxia.

Further, it was also reported that administration of precooled LA at 4-6 Â°C resulted in faster onset and improved anesthetic efficacy in both maxillary and mandibular molars in patients diagnosed with SIP. Cooling of LA increases the pKa value of lignocaine and this would further increase the cation to base ratio enhancing the anaesthetic potency, as cation form is the principal active local anaesthetic molecule.

A careful review of literature revealed that, the effect of intraoral cryotherapy application on pulpal anaesthesia following IANB administration using precooled LA 4-6 ºC in mandibular molars in SIP patients have not yet been reported. Further, comparative evaluation of precooled and conventional LA combined with intraoral cryotherapy application on the success of IANB anaesthesia has also not been studied (4). In addition, intraoral cryotherapy application was done for 5 mins in previous research studies.. Hence, the aim of the present study is to comparatively assess the pain on injection, onset and efficacy of pulpal anaesthesia following IANB using conventional LA and precooled LA 4-6 ºC with and without intraoral cryotherapy application for 2 minutes during endodontic treatment of mandibular molars in SIP patients. The proposed null hypothesis is that administration of precooled LA for IANB anaesthesia followed by intraoral cryotherapy application does not have any effect on the pain on injection, onset and efficacy of pulpal anaesthesia when compared to conventional LA.
 
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