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Applying topical anesthetic gels in children before dental injections may reduce the pain on injection.

Evaluation of cytotoxicity, stability of herbal gel and Comparative pain perception of Herbal topical anesthetic gel and 5 percentage lignocaine gel (Septodont) prior to intraoral local anesthesia in children aged 4-8 years old: Randomised single-blind Split-mouth study. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072242
Enrollment
90
Registered
2024-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

None listed

Sponsors

D Y Patil deemed to be university school of dentistry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary teeth indicated for endodontic procedures or extraction among children ranging between 4-8 years of age. 2. Children exhibiting cooperative behavior (Frankl Behavior rating 3 and 4). 3. Children with no history of intra-oral injections administered previously.

Exclusion criteria

Exclusion criteria: Children with the presence of swelling or any periapical pathology. 2) Children with a medical condition affecting compliance. 3) Children allergic to lidocaine / herbal topical anesthetic gel. 4) Active pathology at the application site. 5) Children with underlying vascular or immunological diseases. 6) Children whose parents did not give consent for the study.

Design outcomes

Primary

MeasureTime frame
To compare efficacy of prior application of spilanthes acmella gel versus lignocaine gel in minimizing dental injection painTimepoint: 1 minute after application of spilanthes acmella gel

Secondary

MeasureTime frame
To assess the safety by cytotoxicity testing of herbal topical anesthetic gel.Timepoint: At baseline

Countries

India

Contacts

Public ContactDrMansi Baviskar

D. Y. Patil deemed to be university, D.Y.Patil School of dentistry

mansi.baviskar@dypatil.edu09821605619

Outcome results

None listed

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