| CTRI Number |
CTRI/2025/06/089676 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Numbing Gels (Atricaine vs. Lidocaine) for Pain Relief During Cavity Treatment in Kids |
|
Scientific Title of Study
|
Comparative Evaluation of Atricaine and Lidocaine Hydrogels for Pain Management in Deep Carious Lesions in Children: A Randomized Controlled 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 |
ashishamudha011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh R |
| Designation |
Assistant 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 |
9895725236 |
| Fax |
|
| Email |
drrameshravikumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh R |
| Designation |
Assistant 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 |
9895725236 |
| Fax |
|
| Email |
drrameshravikumar@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 |
Articaine Hydrogel |
0.24% Articaine hydrogel applied 5 minutes before the procedure |
| Intervention |
Lidocaine Hydrogel |
0.6% lidocaine hydrogel given 5 minutes before the procedure |
| Comparator Agent |
No topical anesthetic was applied |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient reporting to the dental operatory for the first time to minimize behavioural bias
2.Patients from the age group 5 to 10
3.Children not requiring pulp therapy procedures
4.Individuals without any cognitive or systemic disabilities |
|
| ExclusionCriteria |
| Details |
1.Children with prior dental experience
2.Patients with developmental or linguistic disorders who cannot communicate properly
3.Children with medications which affect behaviour
4.Medically and systematically compromised patients
5.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 Wong Baker 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="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This randomized controlled trial evaluated the effectiveness of Atricaine hydrogel versus Lidocaine hydrogel for pain control during the treatment of deep cavities in children aged 5–10 years. The study involved three groups (Atricaine, Lidocaine, and a control) and measured pain levels using standardized scales (e.g., FLACC or Wong-Baker FACES). Results indicated whether Atricaine provided superior, equivalent, or inferior anesthesia compared to Lidocaine, with implications for clinical practice in pediatric dentistry. The sample size was calculated to ensure statistical power, accounting for potential dropouts. Findings aim to guide dentists in choosing the most effective and child-friendly topical anesthetic for managing discomfort during caries treatment. |