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CTRI Number  CTRI/2022/10/046800 [Registered on: 26/10/2022] Trial Registered Prospectively
Last Modified On: 24/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISION OF PAIN PERCEIVED BETWEEN TWO LOCAL ANAESTHETICS FOR ROOT CANAL TREATMENT OF ADULTS. 
Scientific Title of Study   COMPARATIVE EVALUATION OF PAIN PERCEPTION DURING LOCAL ANAESTHETIC DELIVERY AND ANAESTHETIC EFFICACY OF 4% ARTICAINE AND 4% BUFFERED ARTICAINE IN PERMANENT MAXILLARY MOLAR BUCCAL INFILTRATION IN PATIENTS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS - A RANDOMIZED CONTROLLED TRIAL. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishnavi Patankar 
Designation  M.D.S Postgraduate Student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302 3rd floor Department of Conservative Dentistry and Endodontics Bharati Vidyapeeth Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai 400614 MAHARASHTRA

Thane
MAHARASHTRA
400614
India 
Phone  9766820931  
Fax    
Email  vaishnavipatankar597@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Jain 
Designation  Head of Department and Guide 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302 3rd floor Department of Conservative Dentistry and Endodontics Bharati Vidyapeeth Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai 400614 MAHARASHTRA

Thane
MAHARASHTRA
400614
India 
Phone  9869152905  
Fax    
Email  drakjain5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi Patankar 
Designation  M.D.S Postgraduate Student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302 3rd floor Department of Conservative Dentistry and Endodontics Bharati Vidyapeeth Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai 400614 MAHARASHTRA

Thane
MAHARASHTRA
400614
India 
Phone  9766820931  
Fax    
Email  vaishnavipatankar597@gmail.com  
 
Source of Monetary or Material Support  
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL NAVI MUMBAI, MAHARASHTRA, INDIA 
Dr Vaishnavi Patankar 
 
Primary Sponsor  
Name  Dr Vaishnavi Patankar 
Address  Room no 302 3rd floor Department of Conservative Dentistry and Endodontics Bharati Vidyapeeth Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai 400614 Mumbai MAHARASHTRA 400614 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 Vaishnavi Patankar  Bharati Vidyapeeth Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai  Room no 302 3rd floor Department of Conservative Dentistry and Endodontics Bharati Vidyapeeth Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai 400614 MAHARASHTRA
Thane
MAHARASHTRA 		 9766820931

vaishnavipatankar597@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  4% Articaine with Adrenaline 1: 1,00,000 units (Septanest) Local anaesthetic infiltration  Dose: 1.7mL Frequency: once Route of administration: supraperiosteal injection/local infiltration Duration of administration: 1min 
Intervention  4% Buffered Articaine Articaine (Septanest) added with 8.4% sodium bicarbonate solution Local anaesthetic infiltration  Dose: 1.7mL of buffered articaine Frequency: once Route of administration: Supraperiosteal injection local infiltration Duration of administration: 1min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients older than 18 years and younger than 60 years of either gender.
2. Patients who have symptomatic irreversible pulpitis and indicated for root canal treatment.
3. Cooperative healthy patients who are willing to participate in the study and sign the consent form.
 
 
ExclusionCriteria 
Details  1. Patients younger than 18 or older than 60 years.
2. Subjects taking any medication such as analgesics, narcotics, sedatives, or antidepressants that may affect anaesthetic assessment.
3. History of unstable cardiovascular diseases, diabetes, hypertension, pregnancy, asthma, allergies to local anaesthetics, bleeding disorders, neurological conditions.
4. Subjects unable to give informed consent.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The pain scores (VAS) with conventional Articaine and buffered Articaine.  At baseline, immediately after injection 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of action of local anaesthesia  Onset of action of local anaesthesia will be checked 30 seconds after administering injection with the help of electric pulp test. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2022 
Date of Study Completion (India) 26/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Pain during dental treatment is a common fear of patients, which can be controlled successfully by different formulations and techniques of local anaesthetics. Articaine is an amide local anaesthetic solution that substitutes a thiophene ring for the benzene ring present in lidocaine which allows Articaine molecules to diffuse through nerve membranes more effectively than lidocaine molecules, due to increased lipid solubility, resulting in more efficient anaesthesia. Several randomized clinical trials have reported that Articaine is more effective than lidocaine in achieving profound dental pulp anaesthesia particularly following infiltration in the maxilla and as a supplementary infiltration following inferior alveolar nerve block (IANB) in the mandible. Clinical data confirmed that the addition of sodium bicarbonate in local anaesthetics reduces pain, decreases onset and increases duration of local anaesthesia, as compared to local anaesthetic without it. Buffering local anaesthetic formulations increases the pH, making the formulation closer to physiologic pH which results in elimination of injection burning and pain, reduces direct tissue irritation caused by infiltration of a more acidic compound. Once buffered, the anaesthetic formulation will have a higher pH upon injection and more deionized base form will be available to penetrate the nerve sheath and provide anaesthesia even in cases of infection. Hence this study is designed to evaluate pain perception during Local Anaesthetic delivery and Anaesthetic Efficacy of 4% Articaine and 4% Buffered Articaine in Permanent Maxillary Molar Buccal Infiltration in patients with symptomatic irreversible pulpitis. 
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