| CTRI Number |
CTRI/2025/06/089852 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing a Numbing Gel with Clove Oil for Pain Free Crown Fittings in childrens Teeth with severe cavities Without Root canal Treatment |
|
Scientific Title of Study
|
Efficacy of Lidocaine Hydrogel with Eugenol as a Topical Anesthetic for Pain Management During Crown Preparation in Pediatric Teeth Without Pulp Therapy: 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 |
Ganesh Jeevanandhan |
| Designation |
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 |
9884293869 |
| Fax |
|
| Email |
ganesh.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Jeevanandhan |
| Designation |
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 |
9884293869 |
| Fax |
|
| Email |
ganesh.sdc@saveetha.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 |
Lidocaine hydrogel with Eugenol extract |
0.6% lidocaine hydrogel with eugenol in 60 ppm given in 10 seconds and allowed to sit for 5 minutes before starting the procedure |
| Comparator Agent |
Topical anesthetic spray |
Nummit Spray of Lidocaine 7.5mg spray given in 10 seconds and allowed to sit for 5 minutes before starting the procedure |
|
|
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 |
at 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)= "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)
|
11/07/2025 |
| 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="1"
Days="0" |
|
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
|
This randomized controlled trial assessed the efficacy of Lidocaine Hydrogel with Eugenol as a topical anesthetic for pain control during crown preparations in children (aged 5–10 years) without the need for pulpectomy or pulp therapy. The study compared two groups—one receiving the Lidocaine-Eugenol hydrogel and the other a control (standard care or placebo)—and evaluated pain response using validated scales (e.g., FLACC, Wong-Baker FACES, or physiological measures). The sample size was calculated to detect clinically meaningful differences in pain reduction while accounting for potential attrition. Results determined whether this combination provided faster, longer-lasting, or better-tolerated anesthesia compared to conventional methods, offering a potential minimally invasive alternative for managing discomfort during pediatric restorative procedures |