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CTRI Number  CTRI/2024/04/065909 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain management by using topical agents ice and benzocaine gel during anesthetic injection through computer controlled local delivery system  
Scientific Title of Study   Comparative Evaluation of Effectiveness of Benzocaine Gel & Ice for Pain Management in Children During Local Anaesthetic Administration By CCLD, 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  Dr Anija C K 
Designation  Post Graduate student 
Affiliation  Government Dental College and Hospital, Nagpur  
Address  Department of pediatric dentistry Government dental college and Hospital GMC campus Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9400217916  
Fax    
Email  anijacekey916@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anija C K 
Designation  Post Graduate student 
Affiliation  Government Dental College and Hospital, Nagpur  
Address  Department of pediatric dentistry Government dental college and Hospital GMC campus Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9400217916  
Fax    
Email  anijacekey916@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nupur Ninawe  
Designation  Associate Professor  
Affiliation  Government Dental College and Hospital, Nagpur  
Address  Department of pediatric dentistry Government dental college and Hospital GMC campus Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9923765602  
Fax    
Email  nupurgovind@gmail.com  
 
Source of Monetary or Material Support  
Self funded. Government Dental College and Hospital Nagpur 
 
Primary Sponsor  
Name  Dr Anija C K 
Address  Department of pediatric dentistry, Government dental college and hospital GMC campus medical square, Nagpur 440003 Nagpur MAHARASHTRA 440003 India  
Type of Sponsor  Other [Self funded] 
 
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 Anija C K  Government dental college and hospital, Nagpur   Department of pediatric dentistry, Government dental college and hospital GMC campus medical square, Nagpur 440003 Nagpur MAHARASHTRA 440003 India Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 9400217916

anijacekey916@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Government Dental College & Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  with dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  local anaesthetic administration with computer controlled local delivery system after application of Benzocaine gel as topical agent  Benzocaine gel will be used as a topical agent on the site of anaesthetic administration with computer controlled local delivery system 
Intervention  local anaesthetic administration with computer controlled local delivery system after application of ice as topical agent  Ice pack will be used as a topical agent on the site of anaesthetic administration with computer controlled local delivery system 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  • Healthy children (ASA I) of age 5 to 10 years
• Children requiring maxillary buccal infiltration anaesthesia for dental procedures (extraction, restorations, crown preparation, pulp therapy) in both the quadrants.
• Frankl’s behaviour rating grade III or IV
• Children not taking any analgesics or other drugs that would influence their perception of pain
• Completion of informed consent to participate in the study by parents
 
 
ExclusionCriteria 
Details  • Medically compromised condition
• Any allergy to local anaesthesia
• Active pathology at the site of injection
• Prior history of dental treatment
• Frankl’s behaviour rating Grade I or II
• Children with cold hyper sensitivity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare objective pain, measured by Modified Behavioral Pain Scale during administration of local anaesthetic via CCLD with the application of topical agent, ice and benzocaine gel.
2. To evaluate and compare subjective pain, measured by the Wong-Baker Faces pain rating scale, after administration of local anaesthetic via CCLD with the application of topical agent, ice and benzocaine gel.
 		 At the time of injection 
 
Secondary Outcome  
Outcome  TimePoints 
3. To evaluate and compare the comfort of patient during administration of local anaesthetic via CCLD with the application of topical agent, ice and benzocaine gel.  At the time of injection 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   06/05/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is a Split Mouth, Single Blinded, Randomized Controlled Clinical Trial. Healthy children aged between 5 to 10 years requiring maxillary bilateral local anaesthesia for dental procedures will be selected. Patient will be selected from OPD based on inclusion criteria. there will be two groups. Group I, Local anaesthetic administration with the CCLD after the application of ice as a topical agent. Group II – Local anaesthetic administration with the CCLD after the application of benzocaine gel as topical agent. At first visit, half of the population according to randomization will be received intervention treatment. After 7 days same patients will be recalled and control treatment will provide. The other half of the population, according to randomization, will  receive the control treatment, and after 7 days, the same patients will be recalled, and intervention treatment will be provided. The objective pain will be evaluated by Modified Behavioral Pain Scale. Subjective pain will be analysed by Wong-Baker Faces pain rating scale. 
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