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CTRI Number  CTRI/2021/09/036135 [Registered on: 01/09/2021] Trial Registered Prospectively
Last Modified On: 20/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of the effectiveness, pain perception and adverse effects of warm local anaesthetic solution with the conventional local anaesthetic technique in 7 - 9 years children 
Scientific Title of Study   A COMPARATIVE EVALUATION OF THE EFFICACY, PAIN PERCEPTION, HEMODYNAMIC CHANGES AND ADVERSE EFFECTS OF WARM LOCAL ANAESTHETIC SOLUTION DELIVERED ON PRE-COOLED INJECTION SITES WITH THE CONVENTIONAL LOCAL ANAESTHETIC TECHNIQUE IN 7 - 9 YEARS CHILDREN: AN IN VIVO RANDOMIZED SPLIT MOUTH CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha Chittora 
Designation  Post Graduate Student 
Affiliation  Pacific Dental College and Hospital 
Address  Pacific Dental College and Hospital Debari Udaipur Rajasthan

Udaipur
RAJASTHAN
313024
India 
Phone  6291025403  
Fax    
Email  chittoramegss@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Rao 
Designation  Professor and Head 
Affiliation  Pacific Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry Pacific Dental College and Hospital, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Megha Chittora 
Designation  Post Graduate Student 
Affiliation  Pacific Dental College and Hospital 
Address  Pacific Dental College and Hospital Debari Udaipur Rajasthan

Udaipur
RAJASTHAN
313024
India 
Phone  6291025403  
Fax    
Email  chittoramegss@gmail.com  
 
Source of Monetary or Material Support  
Pacific Dental College and Hospital, Udaipur 
 
Primary Sponsor  
Name  Megha Chittora 
Address  Pacific Dental College and Hospital Debari Udaipur Rajasthan 
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 
Megha Chittora  Pacific Dental College and hospital  Room No. 9, Department of Pediatric and Preventive Dentistry
Udaipur
RAJASTHAN 		 6291025403

chittoramegss@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pacific Dental College and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers visiting the Department OPD 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% lignocaine solution (unwarmed) and 2% Lignocaine hydrochloride gel   2% Lignocaine hydrochloride gel applied topically at the site of injection and administration of 2% lignocaine solution (unwarmed) during inferior alveolar nerve block 
Intervention  Prewarmed 2% Lignocaine solution and iced cube  Administration of pre-warmed local anesthetic solution on pre-cooled injected sites using inferior alveolar nerve block 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Medically fit children aged between 7 to 9 years.
2. Children who are mentally capable of communication and those who can follow the instructions and able to interpret the pain perception appropriately.
3. Having mandibular primary molar tooth that require extraction or pulp therapy bilaterally or requiring at least two clinical sessions of pulp therapy procedures.
4. Requiring bilateral inferior alveolar nerve block, without any history of receiving dental injections.
5. Children, who are cooperative enough to undergo dental procedures
6. Parental informed written consent provided
7. Tooth which will give a baseline reading on pulp tester before administration of local anesthetic.
 
 
ExclusionCriteria 
Details  1. Patients with acute signs and symptoms requiring emergency treatment, with previous painful dental experience, and who were medically compromised were excluded from the study
2. History of any post-traumatic stress disorders or specific phobia related to dental settings.
3. History of systemic mental or physical disorders.
4. Children with allergic reactions to lidocaine.
5. Children with cold hypersensitivity and underlying vascular or immunological diseases were excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Administration of warm local anaesthetic solution on pre-cooled injection sites may create reduction in pain perception and may provide better anesthesia in children when compared to conventional local anaesthetic technique during inferior alveolar nerve block anesthesia
 		 Immediately after administration of local anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
Administration of warm local anaesthetic solution on pre-cooled injection sites may provide less adverse effects and hemodynamic changes when compared to conventional local anesthetic technique   Hemodynamic changes will be evaluated immediately at the time of administration of local anesthesia and adverse effects will be evaluated after 24 hours  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   02/09/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [chittoramegss@gmail.com].

  6. For how long will this data be available start date provided 26-09-2024 and end date provided 26-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

This is an in vivo randomized controlled experimental split mouth study, involving 70 children in the age group of 7 – 9 yrs which will require bilateral anaesthesia for different dental procedures in primary mandibular molars. By a split mouth design, selected children will be randomly allocated to receive 2% lignocaine with either technique a or b during the first or second appointment of treatment procedure.

Technique A: During the visit, precooling of the site of injection was done up to 2 mins and after that warmed local anaesthetic solution was administered on one side of the arch using 2 % lignocaine.

Technique B: During the visit, lidocaine hydrochloride 2% topical gel being applied on the site of injection and local anesthesia will be administered by the conventional technique using 2% lignocaine. The operative procedure carried out will be similar for all children and will be completed in the same appointment and by the same operator. The subject will be blinded for the drug being used and will not have any involvement with testing the outcome. A minimum of             1-week time difference will be maintained between the two appointments to avoid the effect of carry over phenomenon in children. After the administration of local anesthesia, selected children will be evaluated on the following parameters: Pain perception, onset of anesthesia, duration of anesthesia, hemodynamic changes and adverse effects. The expected conclusion of this study will be that administration of warm local anaesthetic solution on pre-cooled injection sites may create reduction in pain perception and may provide better anesthesia with less adverse effects in children when compared to conventional local anaesthetic technique.

 
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