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CTRI Number  CTRI/2025/05/087625 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 25/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Study Comparing Two Types of Dental Anesthesia for numbing children teeth 
Scientific Title of Study   Comparative Study to Evaluate the Anesthetic Efficacy and Pain Perception of Buffered 4% Articaine Versus Buffered 2% Lidocaine with Local Anesthesia in Children : A Randomized Split Mouth Control 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  Ashish Suresh 
Designation  Post Graduate Student 
Affiliation  Saveetha Dental College and Hospitals 
Address  Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India

Thiruvallur
TAMIL NADU
600077
India 
Phone  9884927585  
Fax    
Email  152411001.sdc@saveetha.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunnypriyatham Tirupathi 
Designation  Associate Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India

Thiruvallur
TAMIL NADU
600077
India 
Phone  9490549454  
Fax    
Email  dr.priyatham@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sunnypriyatham Tirupathi 
Designation  Associate Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India


TAMIL NADU
600077
India 
Phone  9490549454  
Fax    
Email  dr.priyatham@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Dental College and Hospitals, SIMATS University, No 162, Poonamalle High Road, Velappanchavadi, Chennai-600077, Tamil Nadu, India. 
 
Primary Sponsor  
Name  Ashish Suresh 
Address  Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, 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 Ashish Suresh  Saveetha Dental College and Hospitals   Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU 
9884927585

152411001.sdc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) Registered under Government of India (Registration No. ECR/1698/Inst/TN/2022)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buffered 2% Lidocaine  2% Lidocaine in 1:100000 dilution with epinephrine mixed with 8.4% sodium bicarbonate in 10:1 ratio Intervention will be for the duration of the injection which will be around 40 to 60 seconds  
Intervention  Buffered 4% Articaine  4% Articaine in 1:100000 dilution with epinephrine mixed with 8.4% sodium bicarbonate in 10:1 ratio Intervention will be for the duration of the injection which will be around 40 to 60 seconds  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children who are between 6 to 12 years old
2.Healthy children (ASA I)
3.Body weight within the Inter Quartile Range (IQR) for this age group as defined by the Centers for Disease Control and Prevention
4.Willingness to participate in two sessions
5.No history of adverse reaction to anesthetic.
6.Children with no Physical or Cognitive disablities
7.Patient reporting to the dental operatory for the first time to minimize behavioural bias
8.Children requiring pulp therapy procedures 
 
ExclusionCriteria 
Details  1.Allergy to lidocaine anesthetic drugs
2.Local anesthetic drug administered within the week before the session in which they participated
3.Highly symptomatic teeth
4.Localised Lesion at the site of infection
5.Children with prior dental experience
6.Patients with developmental or linguistic disorders who cannot communicate properly
7.Children with medications which affect behaviour
8.Medically and systematically compromised patients
9.Patients with cognitive impairments or special needs  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain perception using VAS and FLACC scale  At baseline  
 
Secondary Outcome  
Outcome  TimePoints 
The start of the action, duration of postoperative analgesia, & occurrence of any problems. The duration of
anesthesia was assessed by the feeling of numbness & the first sign of pain.  
At baseline  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   05/06/2025 
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="0"
Months="0"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Effective pain management is a crucial aspect of pediatric dentistry, as it directly affects a child’s comfort, cooperation, and overall experience during dental procedures. Achieving adequate anesthesia is essential for minimizing discomfort and anxiety, allowing for smoother treatments. Local anesthetics play a key role in pain control, with lidocaine being the most commonly used due to its well-established safety and efficacy. However, articaine has gained attention in recent years because of its enhanced diffusion ability, which may provide better anesthesia, particularly in areas with dense bone.

One technique that has been introduced to improve the effectiveness of local anesthetics is buffering, which involves adjusting the anesthetic solution’s pH to be closer to physiological levels. This method has been found to decrease injection pain, speed up the onset of anesthesia, and enhance its overall performance by increasing the availability of active anesthetic molecules. Although both articaine and lidocaine can be buffered, limited research has directly compared their effectiveness in pediatric patients.

This study aims to evaluate the clinical efficacy of buffered 4% articaine versus buffered 2% lidocaine in pediatric dental procedures using a randomized crossover split-mouth design. The primary focus will be on anesthetic onset time, pain perception during injection, and the duration of anesthesia. By analyzing these factors, the study seeks to determine whether buffered articaine provides any significant advantages over buffered lidocaine, offering insights that may help improve pain management strategies in pediatric dentistry

 
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