Comparison of a natural Clove-Chamomile gel and Lignocaine gel to reduce injection pain in children during dental treatment

Comparative evaluation of Clove-Chamomile gel Vs Lignocaine gel as Topical Anaesthetic Prior to Local Anaesthesia in Children: A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094137

Enrollment

Registered

2025-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

None listed

Interventions

Intervention1: Clove-Chamomile gel and Lignocaine gel: Children in Group 1 will receive Clove-Chamomile Gel applied with a cotton applicator on the oral mucosa for 1 minute before local anaesthesia ad

Eligibility

Inclusion criteria

Inclusion criteria: 8-12 years old children Children who are willing to participate in the study. Children requiring LA for dental procedures Children with no cognitive disorders

Exclusion criteria

Exclusion criteria: Special health care need Children Recent trauma to oral tissues Children with a history of hypersensitivity reactions to any components present in the anaesthetic agents

Design outcomes

Secondary

Measure	Time frame
Physiological response measured by pulse rate recorded with a pulse oximeter before, during, & after local anaesthesia administration.Timepoint: Pulse rate (physiological parameter) is measured Before LA administration (baseline), During LA administration and Immediately after LA administration Time points: Pulse rate will be measured before, during, & immediately after local anaesthesia administration.	—

Measure

Time frame

Physiological response measured by pulse rate recorded with a pulse oximeter before, during, & after local anaesthesia administration.Timepoint: Pulse rate (physiological parameter) is measured Before LA administration (baseline), During LA administration and Immediately after LA administration Time points: Pulse rate will be measured before, during, & immediately after local anaesthesia administration.

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Primary

Measure	Time frame
Pain perception during local anaesthesia administration, assessed using the Sound-Eye-Motor (SEM) scale (objective) and the Oucher pain scale (subjective).Timepoint: Pain perception is measured During LA administration by SEM scale (objective) and Immediately after LA administration by Oucher pain scale (subjective) Time points: During LA administration (SEM); Immediately after LA administration (within 1 minute) (Oucher).	—

Measure

Time frame

Pain perception during local anaesthesia administration, assessed using the Sound-Eye-Motor (SEM) scale (objective) and the Oucher pain scale (subjective).Timepoint: Pain perception is measured During LA administration by SEM scale (objective) and Immediately after LA administration by Oucher pain scale (subjective) Time points: During LA administration (SEM); Immediately after LA administration (within 1 minute) (Oucher).

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Countries

India

Contacts

Public ContactGanganapalli Reddy Sravya

Narayana Dental College and Hospital, Nellore

nimskrishna2007@gmail.com9440206976

Outcome results