effect of local 2.5%lidocaine 2.5% prilocaine anesthetic gel in reducing the pain of needle insertion in palatal anesthesia

Investigating the effect of local 2.5%lidocaine 2.5% prilocaine anesthetic gel with benzocaine 20% gel in reducing the pain of needle insertion in palatal anesthesia of 9-12 year old children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250715066500N1

Enrollment

Registered

2025-08-17

Start date

2025-09-23

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Healthy patients with ASA 1 and 2. Dental drugs, topically applied

Interventions

Intervention 1: Intervention Group:A topical anesthetic gel (containing 2.5% prilocaine and 2.5% lidocaine w/v, carbopol P974 polymer, methylparaben, propylparaben, glycerin, and sodium saccharin), pr

Eligibility

Sex/Gender

All

Age

9 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 9 to 12 years without abscess classified as ASA1 or ASA2 with no intellectual disability free from mental or psychological disorders no hypersensitivity to topical or local anesthetics exhibiting cooperative behavior categorized as Frankel scale group 3 or 4 having no prior dental treatment or negative dental experiences without fistula in the target area

Exclusion criteria

Exclusion criteria: use of analgesic medications use of or anti-inflammatory medications presence of oral inflammation lack of consent or withdrawal of cooperation

Design outcomes

Primary

Measure	Time frame
The reduction in pain associated with needle insertion during palatal infiltration anesthesia, measured using the Visual Analog Scale (VAS) on a 0–100 range, evaluating the efficacy of 2.5% lidocaine/prilocaine gel compared to 20% benzocaine gel in children aged 9 to 12 years. Timepoint: 2-3 minutes. Method of measurement: The Visual Analog Scale (VAS), ranging from 0 to 100, incorporates five emojis to facilitate better understanding by children aged 9 to 12 years, enhancing their ability to report pain intensity intuitively.	—

Measure

Time frame

The reduction in pain associated with needle insertion during palatal infiltration anesthesia, measured using the Visual Analog Scale (VAS) on a 0–100 range, evaluating the efficacy of 2.5% lidocaine/prilocaine gel compared to 20% benzocaine gel in children aged 9 to 12 years. Timepoint: 2-3 minutes. Method of measurement: The Visual Analog Scale (VAS), ranging from 0 to 100, incorporates five emojis to facilitate better understanding by children aged 9 to 12 years, enhancing their ability to report pain intensity intuitively.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzam Nahvi

Mazandaran University of Medical Sciences

azamnahvi.pedodontist@gmail.com+98 11 3324 4894

Outcome results

None listed

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