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CTRI Number  CTRI/2024/12/077696 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized Factorial Trial 
Public Title of Study   Comparison between computer controlled injection and conventional technique in its efficacy for Inferior Alveolar Nerve Block  
Scientific Title of Study   To compare Computer controlled injection Technique with Conventional Technique for Inferior Alveolar Nerve Block in its efficacy - A Randomized 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  Esrapal C 
Designation  PG student 
Affiliation  Sree Mookambika Institute of Dental Science 
Address  Department of oral and maxillofacial surgery, Sree Mookambika Institute of Dental Sciences, Kulasekharam.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  8778139853  
Fax    
Email  esrapalezra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sajesh 
Designation  Professor  
Affiliation  Sree Mookambika Institute of Dental Science 
Address  Department of oral and maxillofacial surgery, Sree Mookambika Institute of Dental Sciences, Kulasekharam.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9486941236  
Fax    
Email  sajeshnair79@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Sajesh 
Designation  Professor 
Affiliation  Sree Mookambika Institute of Dental Science 
Address  Department of oral and maxillofacial surgery, Sree Mookambika Institute of Dental Sciences, Kulasekharam.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9486941236  
Fax    
Email  sajeshnair79@yahoo.co.in  
 
Source of Monetary or Material Support  
NO.2 , Department of Oral and Maxillofacial Surgery, Sree Mookambika Institute of Dental Science, V.P.M HOSPITAL COMPLEX, PADANILAM KULASHEKHARAM, KANYAKUMARI DISTRICT TAMIL NADU - 629161 India 
 
Primary Sponsor  
Name  Esrapal C 
Address  NO.2 , Department of Oral and Maxillofacial Surgery, Sree Mookambika Institute of Dental Science, V.P.M HOSPITAL COMPLEX, PADANILAM KULASHEKHARAM, KANYAKUMARI DISTRICT TAMIL NADU - 629161 India 
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 Esrapal C  SREE MOOKAMBIKA INSTITUTE OF DENTAL SCIENCES  NO.2 , Department of Oral and Maxillofacial Surgery, Sree Mookambika Institute of Dental Science, V.P.M HOSPITAL COMPLEX, PADANILAM KULASHEKHARAM - 629161 KANYAKUMARI DISTRICT
Kanniyakumari
TAMIL NADU 		 8778139853

esrapalezra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Human Ethics committee (IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K010||Embedded teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Computer controlled injection technique  computer controlled injection technique for inferior alveolar nerve block using 2% lignocaine with 1:80000 adrenaline at a rate of 1.8 ml/min to assess pain during injection, onset of anesthetic effect, change in heart rate, blood pressure, respiratory rate. 
Comparator Agent  conventional injection technique  conventional injection technique for inferior alveolar nerve block using 2% lignocaine with 1:80000 adrenaline at a rate of 1.8 ml/min to assess pain during injection, onset of anesthetic effect, change in heart rate, blood pressure, respiratory rate. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who require tooth extraction on both sides.
Both men & women
Age between 20-60
 
 
ExclusionCriteria 
Details  Patients suffering from systemic illness predisposing them to immunocompromised
state (Diabetes Mellitus, long – term steroid therapy, hemostatic alterations)
Pregnant Patients
Patient with acute infectious conditions in the oral cavity
Poor oral hygiene
Patient on analgesics
Patient allergic to lignocaine
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Computer-controlled injection Technique has less pain on injection when compared with
conventional Technique for Inferior Alveolar nerve block. 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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 2 
Date of First Enrollment (India)   01/12/2025 
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 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 randomized clinical trial , block randomization, on patient requires extraction on both sides of the mandible within the age limit of 20-60 years. By comparing the conventional and computer controlled injection technique in inferior alveolar nerve block in pain perception, vital sign changes before and after injections.  
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