Comparative Study of Herbal and Conventional Topical Gels to Reduce Injection Pain in Children Aged 6 10 Years

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. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095051

Enrollment

Registered

2025-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K038- Other specified diseases of hard tissues of teeth Health Condition 2: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: 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 p

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To determine whether herbal gels like Spilanthes acmella and betel leaf extract offer comparable or superior pain reduction relative to benzocaine.Timepoint: Pre operative and immediately post operative	—

Secondary

Measure	Time frame
To establish safe, effective, & child-friendly alternatives for topical anesthesia in pediatric dentistry.Timepoint: NA	—

Countries

India

Contacts

Public ContactSiddhi Shinde

SMBT Dental College and Hospital Sangamner

vinayakumar53@gmail.com8369062570

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026