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
|
|
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
|
|
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 |