| CTRI Number |
CTRI/2025/05/087546 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
25/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study Comparing Two Types of drugs for numbing children teeth |
|
Scientific Title of Study
|
Comparative Study to Evaluate the Anesthetic Efficacy and Pain Perception of Buffered 4 percent Articaine Versus Non-buffered 4 percent Articaine with Local Anesthesia in Children : A Randomised 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 |
| 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 |
ashishamudha011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunnypriyatham Thirupathi |
| Designation |
Associate professor |
| Affiliation |
Saveetha Dental College |
| 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 Thirupathi |
| Designation |
Associate professor |
| Affiliation |
Saveetha Dental College |
| 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
ashishamudha011@gmail.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 |
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 |
| 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 |
| Comparator Agent |
Non Buffered 4% Articaine |
4% Articaine in 1:100,000 dilution without the addition of Sodium Bicarbonate. 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 articaine 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 the 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
|
Phase 2/ Phase 3 |
|
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 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
|
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. Ensuring adequate anesthesia is essential to minimizing discomfort and anxiety, which can influence a child’s willingness to undergo treatment. Local anesthetics serve as the primary method for pain control in dentistry, with lidocaine being the most commonly used due to its well-documented safety and reliability. However, articaine has gained popularity in recent years due to its superior ability to diffuse through tissues, making it particularly beneficial in regions with dense bone structures.
One common challenge with local anesthesia is the discomfort associated with injections, as well as variability in the time it takes for the anesthetic to take effect and how long it lasts. To improve the efficiency and comfort of anesthesia, buffered anesthetic solutions have been introduced. These formulations work by adjusting the pH of the anesthetic to be closer to the body’s natural levels, which can help reduce pain during injection, speed up the onset of anesthesia, and improve its overall effectiveness.
The purpose of this study is to evaluate the clinical performance of buffered 4% articaine compared to non-buffered 4% Articaine in pediatric dental procedures using a randomized crossover split-mouth design. The study will focus on key factors such as the time it takes for the anesthetic to take effect, the level of pain experienced during injection, and the duration of numbness achieved. By analyzing these aspects, the research aims to determine whether buffered articaine offers significant advantages over conventional non-buffered articaine in managing pain for pediatric dental patients. |