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CTRI Number  CTRI/2025/08/092750 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 09/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Reducing Injection Pain During Dental Anesthesia: A Comparison of Numbing Gel and Ice Therapy. 
Scientific Title of Study   Comparative evaluation of injection pain during administration of local anaesthesia after topical anaesthetic gel versus cryotherapy application: A randomised controlled 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 Sunayana Bidave 
Designation  Post Graduate student  
Affiliation  RD Dental Collge and Research Centre, Nagpur 
Address  311 Department of Conservative Dentistry and Endodontics

Nagpur
MAHARASHTRA
440019
India 
Phone  9405389193  
Fax    
Email  sbidave155@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratima Shenoi 
Designation  HOD and Guide 
Affiliation  RD Dental College and Research Centre Nagpur 
Address  311 Department of Conservative Dentistry and Endodontics

Nagpur
MAHARASHTRA
440019
India 
Phone  9822220506  
Fax    
Email  prshenoi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunayana Bidave 
Designation  Post Graduate student  
Affiliation  RD Dental Collge and Research Centre, Nagpur 
Address  311 Department of Conservative Dentistry and Endodontics


MAHARASHTRA
440019
India 
Phone  9405389193  
Fax    
Email  sbidave155@gmail.com  
 
Source of Monetary or Material Support  
Ranjeet Deshmukh Dental College and Research Centre, Nagpur 440019 
 
Primary Sponsor  
Name  Dr Sunayana Bidave 
Address  Hingna Road, Digdoh hills, Police Nagar, Nagpur 440019 
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 Sunayana Bidave  RD Dental College and Research Centre, Nagpur  311 Department of Conservative Dentistry and Endodontics
Nagpur
MAHARASHTRA 		 9405389193

sbidave155@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ranjeet Deshmukh Dental College and Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Pain During Administration Of Local Anesthesia   1) Topical Anesthetic Gel (2% lignocaine gel, for 1 min applied on mucosal surface) vs 2)Cryotherapy (sterile distilled water frozen in custom-made polypropylene molds 5 mm × 10 mm applied on mucosal surface for 15 seconds) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients requiring endodontic intervention in atleast two teeth, either in the same or contralateral arch requiring local anaesthesia. 
 
ExclusionCriteria 
Details  Patients allergic to local anaesthetic agent. Patients anxious to local anaesthesia. Patients allergic to any other drugs and/or conditions that influence the pain score. Patients taken any premedication before procedure. Patients who will refuse to give informed consent . Patients with acute infections at the injection site. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain perception during the administration of local anesthesia will be assessed using a Visual Analog Scale (VAS).   At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="17"
Sample Size from India="17" 
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/08/2025 
Date of Study Completion (India) 20/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Introduction: Pain management is a critical component of successful endodontic treatment, particularly during intraoperative and postoperative stages. Adequate control of pain not only enhances patient comfort but also contributes to overall treatment efficacy and patient compliance. Local anesthetics (LAs) are indispensable in minimizing discomfort associated with a variety of dental, endodontic, and minor surgical procedures.

To minimize injection-related discomfort, a range of strategies has been investigated. These include the use of topical anesthetic gels, precooling techniques (such as ice or refrigerant spray), buffering of anesthetic solutions to reduce acidity and injection pain, and advanced delivery systems like computer-controlled local anesthetic delivery (CCLAD) devices.

Given this gap in evidence, the present clinical trial aims to evaluate and compare the effectiveness of a topical anesthetic gel and cryotherapy in reducing pain perception during the administration of local anesthesia in dental patients.

Aim:  The aim of this study is to compare and evaluate of injection pain during administration of local anesthesia after topical anesthetic gel versus cryotherapy application.

Objectives:

  1. To evaluate the injection pain during administration of local anesthesia after topical anesthetic gel versus cryotherapy application.
  2. To compare the injection pain during administration of local anesthesia after topical anesthetic gel versus cryotherapy application.
Primary Hypothesis: There is a significant difference between the injection pain during administration of local anesthesia after topical anesthetic gel versus cryotherapy application.
Null Hpothesis: There is no significant difference between the injection pain during administration of local anesthesia after topical anesthetic gel versus cryotherapy application.
Study design: Two arm, crossover controlled trial.
Study Population: Patients visiting the Department of Conservative Dentistry and Endodontics for endodntic treatment.
Sample Size: the total sample size estimated was 17 per group.
Group allocation: For patients requiring endodontic or restorative treatment involving two or more teeth, two separate pre-treatment protocols corresponding to their assigned group will be applied—one before anesthesia for each tooth. This approach will be adopted to optimize local anesthesia efficacy across multiple sites, ensuring adequate pain control during treatment of each tooth. The timing of each pre-treatment and injection will be standardized to maintain consistency and reduce variability in anesthetic effectiveness. Group A- Topical Anaesthetic gel. Group B- Cryotherapy.
Pain assessment: Pain perception during the administration of local anesthesia will be assessed using a VAS scale. The VAS will consist of a 10 cm horizontal line, where 0 represents "no pain" and 10 represents the "worst imaginable pain." Each patient will be informed about the purpose and use of the scale prior to the procedure.

 
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