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CTRI Number  CTRI/2022/07/044039 [Registered on: 15/07/2022] Trial Registered Prospectively
Last Modified On: 14/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Other 
Public Title of Study   A clinical study to determine the effectiveness of 2% lignocaine with varying concentration of adrenaline used in dental extraction procedures.  
Scientific Title of Study   Comparison of Anaesthetic Efficacy of 2% Plain Lignocaine and 2% Lignocaine with 1:400000 Adrenaline to 2% Lignocaine with 1:200000 Adrenaline in Dental Extraction Procedures – A Randomized Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namrata Patil 
Designation  I MDS ( Oral and maxillofacial surgery) 
Affiliation  Nair Hospital Dental College 
Address  Nair Hospital Dental College Mumbai Central 400008
Nair Hospital Dental College Mumbai Central 400008
Mumbai
MAHARASHTRA
400008
India 
Phone  9867277017  
Fax    
Email  drnamratapatil10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohan Deshpande 
Designation  Assistant professor ( Oral and maxillofacial surgery) 
Affiliation  Nair Hospital Dental College 
Address  Nair Hospital Dental College Mumbai Central 400008
Nair Hospital Dental College Mumbai Central 400008
Mumbai
MAHARASHTRA
400008
India 
Phone  9867277017  
Fax    
Email  mddomfs1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Namrata Patil 
Designation  I MDS ( Oral and maxillofacial surgery) 
Affiliation  Nair Hospital Dental College 
Address  Nair Hospital Dental College Mumbai Central 400008
Nair Hospital Dental College Mumbai Central 400008
Mumbai
MAHARASHTRA
400008
India 
Phone  9867277017  
Fax    
Email  drnamratapatil10@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral and Maxillofacial Surgery. Nair Hospital Dental College. Mumbai 400008 
 
Primary Sponsor  
Name  Self Dr Namrata Patil 
Address  Samodiya apartments, hanuman road, powai, Mumbai  
Type of Sponsor  Other [Self financed] 
 
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 Namrata Patil  Department of Oral and Maxillofacial Surgery (1st floor)Nair Hospital Dental College   Mumbai Central
Mumbai
MAHARASHTRA 
9867277017

drnamratapatil10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nair Hospital Dental College Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% lignocaine   A total of 25 patients will receive upto 4ml of anesthetic solution once.  
Intervention  2% lignocaine With 1: 2 lakh adrenaline subperiosteal injection.   A total of 25 patients will receive upto 4 mls anesthetic solution once.  
Intervention  2% lignocaine With 1:4 lakh adrenaline subperiosteal injection  A total of 25 patients will receive upto 4 mls anesthetic solution once.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals falling in 40-60 age group.
individuals needing maxillary molar/premolar extractions.
Individuals with controlled hypertension.

 
 
ExclusionCriteria 
Details  Individuals with known H/O of thyroid disorder, renal disease , uncontrolled hypertension ,under antiplatelets & anticoagulant therapy , bronchial asthma and pregnant females
Patients with known allergy to any of the study drugs.
Mentally challenged patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain measured by Visual Analog Scale  5 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Need for suturing  yes/no 
Blood pressure   Mm of Hg by automated sphygmomanometer before and after LA injection and immediately after completion of the extraction procedure. 
Volume of anesthetic agent  ml  
Pulse  Beats per minute before and after injection of local anesthetic and immediately after extraction procedure  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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/ Phase 3 
Date of First Enrollment (India)   18/07/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 Local anaesthetics are used to carry out minor surgical procedures in dentistry. They ensure a painless procedure especially during manipulation of mucosa and bone and thereby proved to minimize anxiety in patients.

         Vasoconstrictors are added to improve the efficiency of the local anaesthetic agent by reducing the rate of absorption from the site of administration thereby minimizing toxicity and prolonging the duration of action. It also reduces haemorrhage thus ensuring a bloodless field for the procedure. Advent of adrenalized local anaesthesia solutions and their ease of administration have enabled the surgeon to perform minor surgeries on a walk in and walk out basis for needy patients and for those patients unfit for general anaesthesia.

      Systemically adrenaline like vasoconstrictors are known to trigger cardiovascular disturbances. These range from tachycardia and raised blood pressure to ventricular fibrillation, myocardial infarction and cerebrovascular accidents. While most are short lived due to rapid absorption and metabolism of adrenaline, the potential risk of serious outcomes increases the chance of threat to life of the patient. Due to the risk of these occurrences adrenalized local anaesthetics are contraindicated for use by cardiologists in patients with known history of hypertension or cardiac disease. However, plain local anaesthesia solutions suffer from the problem of inadequate depth and duration of anaesthesia. This leads to increased endogenous catecholamine release due to the anxiety and fear experienced by the patient secondary to the pain felt at the surgical site thus increasing the potential risk for cardio/cerebrovascular events. 

       In present times due to various factors such as increased stress faced in daily life, the younger population in the 4th decade of life has a significant number of silent members with cardiac disease such as hypertension and coronary insufficiency.  Use of adrenalized LA agents in such subjects with silent cardiac disease during dental procedures may therefore prove to be risky to the patient and invite medico-legal action against the surgeon.

           In view of the increasing incidence of silent cardiac disease in younger population as well as increase in number of senior citizens with known cardiac disease seeking dental surgery this study is proposed to find a golden mean with respect to the safe concentration of adrenaline from the view point of maintaining the efficacy of local anaesthetic without increasing the risk potential to patients with covert/overt cardiac disease.

           At present 2% lignocaine HCL combined with adrenaline in a concentration of 1: 200000 is the most widely used local anaesthetic solution for dental procedure. Patient comfort during extraction and endodontic therapy remain the gold standard for measuring of the local anaesthetic efficacy. In this study it is proposed to compare the efficacy of 2% plain lignocaine with 2% lignocaine combined with adrenaline 1:400000 to 2% lignocaine combined with 1:200000 as the standard (control) solution. The efficacy will be tested on willing patients needing a maxillary molar/premolar extraction in the cardiac risk prone age group of 40-60 years. Pre and post injection blood pressure and pulse will be used as parameters to monitor the haemodynamic changes. Post extraction bleeding will be recorded 30 minutes after the extraction procedure to evaluate the need for suturing for control of post operative bleeding following extraction in all three groups.

 
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