| CTRI Number |
CTRI/2025/09/095051 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Study of Herbal and Conventional Topical Gels to Reduce Injection Pain in Children Aged 6–10 Years |
|
Scientific Title of Study
|
Pain Perception in Pediatric Infiltration
Anesthesia: A Comparative Evaluation of Spilanthes acmella gel Betel Leaf extract gel and
Benzocaine Topical Agent in Children Aged 6-10-years. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
Department of Pediatric and Preventive Dentistry Room No 102
SMBT Dental College and Hospital Amrutnagar Sangamner
Department of Pediatric and Preventive Dentistry Room No 102
SMBT Dental College and Hospital Amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
Department of Pediatric and Preventive Dentistry Room No.102
SMBT Dental College and Hospital Amrutnagar Sangamner
Department of Pediatric and Preventive Dentistry Room No.102
SMBT Dental College and Hospital Amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8369062570 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhi Shinde |
| Designation |
Postgraduate student |
| Affiliation |
SMBT Dental College and Hospital, Sangamner |
| Address |
Department of Pediatric and Preventive Dentistry, Room no 102
SMBT Dental College and Hospital, Amrutnagar, Sangamner
Amrutnagar, Ghulewadi, Sangamner.
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8369062570 |
| Fax |
|
| Email |
drsidshin@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital, Sangamner- 422608
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
SMBT Dental College and Hospital, Sangamner |
| Address |
Amrutnagar, Ghulewadi, Sangamner-422608. |
| Type of Sponsor |
Other [Private dental college and hsopital.] |
|
|
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 |
| DrSiddhi Shinde |
Department of Pediatric and Preventive Dentistry, Room No 102 |
SMBT Dental College and Hospital ,Amrutnagar Sangamner-422608
Ahmadnagar
MAHARASHTRA |
8369062570
drsidshin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental College and Hospital, Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% Benzocaine gel(control) |
Participant Preparation Children aged 6–10 years fulfilling the inclusion and exclusion criteria will be selected after obtaining informed consent from the parent/guardian and assent from the child.
Each child’s behavior will be assessed using the Frankl Behaviour Rating Scale, and only those rated as "positive" or "definitely positive" will proceed.
Participants will be randomly allocated into three groups using a computer-generated randomization sequence: Group A: Spilanthes acmella gel Group B: Betel leaf extract gel Group C: 5% Benzocaine gel Pre-injection Protocol
The area of mucosa (buccal and palatal) indicated for local anesthetic injection will be dried using a sterile cotton roll and air syringe.
A pea-sized amount of the assigned topical anesthetic gel will be applied to the dried mucosa using a cotton-tipped applicator with gentle pressure.
The gel will be allowed to remain undisturbed on the site for 1 full minute to achieve adequate mucosal absorption. No rinsing or suction will be performed during this period. Injection Technique
Following the gel application period, a standard infiltration injection will be administered using a 26-gauge short dental needle.
A total of 0.5–1 mL of 2% lignocaine with 1:100,000 epinephrine will be deposited slowly (over 30 seconds) at the site.
All injections will be performed by a single calibrated operator to ensure standardization. Pain Assessment
Immediately after the injection, the child will be asked to indicate their pain level using the Wong-Baker Faces Pain Rating Scale (WBFPRS) — a validated tool for self-reporting pain in children.
Simultaneously, an independent observer (blinded to the group allocation) will assess the child’s behavioural pain response using the FLACC scale (Face, Legs, Activity, Cry, Consolability).
Both scores will be recorded on a data sheet for analysis.
|
| Comparator Agent |
Spilanthes acmella gel
Betel leaf extract gel
|
Participant Preparation
Children aged 6–10 years fulfilling the inclusion and exclusion criteria will be selected after obtaining informed consent from the parent/guardian and assent from the child.
Each child’s behavior will be assessed using the Frankl Behaviour Rating Scale, and only those rated as "positive" or "definitely positive" will proceed.
Participants will be randomly allocated into three groups using a computer-generated randomization sequence:
Group A: Spilanthes acmella gel
Group B: Betel leaf extract gel
Group C: 5% Benzocaine gel
Pre-injection Protocol
The area of mucosa (buccal and palatal) indicated for local anesthetic injection will be dried using a sterile cotton roll and air syringe.
A pea-sized amount of the assigned topical anesthetic gel will be applied to the dried mucosa using a cotton-tipped applicator with gentle pressure.
The gel will be allowed to remain undisturbed on the site for 1 full minute to achieve adequate mucosal absorption.
No rinsing or suction will be performed during this period.
Injection Technique
Following the gel application period, a standard infiltration injection will be administered using a 26-gauge short dental needle.
A total of 0.5–1 mL of 2% lignocaine with 1:100,000 epinephrine will be deposited slowly (over 30 seconds) at the site.
All injections will be performed by a single calibrated operator to ensure standardization.
Pain Assessment
Immediately after the injection, the child will be asked to indicate their pain level using the Wong-Baker Faces Pain Rating Scale (WBFPRS) — a validated tool for self-reporting pain in children.
Simultaneously, an independent observer (blinded to the group allocation) will assess the child’s behavioural pain response using the FLACC scale (Face, Legs, Activity, Cry, Consolability).
Both scores will be recorded on a data sheet for analysis.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6–10 years.
Frankl positive behavior rating of 3 and 4.(positive/cooperative).
Patients indicated for local anesthesia via infiltration for treatment (extraction procedure).
|
|
| ExclusionCriteria |
| Details |
•Known allergy to any of the topical agents to be used.
•History of systemic illness or neurological disorders.
•Acute infection or inflammation at injection site.
•Specially abled children.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether herbal gels like Spilanthes acmella and betel leaf extract offer comparable or superior pain reduction relative to benzocaine. |
Pre operative and immediately post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish safe, effective, & child-friendly alternatives for topical anesthesia in pediatric dentistry. |
NA |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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="6"
Days="0" |
|
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
|
Title:
Comparative Evaluation of Spilanthes acmella Gel, Betel Leaf Extract Gel, and 5% Benzocaine Gel for Pain Reduction During Pediatric Infiltration Anesthesia: A Randomized Clinical Trial Brief Summary:
This triple-arm, randomized, controlled, single-blinded clinical trial aims to compare the efficacy of three topical anesthetic agents—Spilanthes acmella gel, betel leaf (Piper betle) extract gel, and 5% benzocaine gel—in reducing pain perception during buccal and palatal infiltration injections in children aged 6 to 10 years. A total of 60 healthy pediatric patients requiring infiltration anesthesia for routine dental procedures will be randomly allocated into three groups (n = 20 per group). After standardized application of the assigned topical gel for 1 minute, a local infiltration using 2% lignocaine with 1:100,000 epinephrine will be administered. Pain will be assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS) and FLACC behavioral scale immediately post-injection. Data will be analyzed using ANOVA and post-hoc Tukey tests to determine statistically significant differences in pain perception between the groups. The study seeks to establish whether phyto-based topical anesthetics can serve as effective, safe, and child-friendly alternatives to conventional agents in pediatric dentistry. Primary Objective:
To compare pain perception during infiltration anesthesia following application of Spilanthes acmella gel, betel leaf extract gel, and 5% benzocaine gel. Study Design:
Randomized, controlled, triple-arm, single-blinded clinical trial. Sample Size:
60 children (20 per group), aged 6–10 years. Primary Outcome Measures: Randomization Method:
Computer-generated random allocation sequence. Blinding:
Single-blinded (participant and observer blinded; operator not blinded). Statistical Tools:
Descriptive statistics, ANOVA, Tukey post-hoc test (significance at p < 0.05; SPSS v25). Expected Outcome:
To determine whether Spilanthes acmella or betel leaf gel is comparable or superior to benzocaine in reducing injection pain in pediatric patients. |