COMPARISON OF THE TOPICAL ANAESTHETIC EFFICACY OF VARIOUS AGENTS WITH ANAESTHETIC EFFECTS IN CHILDREN

NCT07849192 | Completed

• 1 other identifier: 581-581-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the effectiveness of natural methods-such as basil oil, chamomile oil, and ice-with synthetic topical anesthetics, such as topical anesthetic sprays and topical anesthetic creams, and to assess their effects on pain and anxiety levels in children. The patient is expected to answer the questions asked by the physician during the procedure.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (3)

• VAS(Visual Analogue Scale)

  The VAS is widely used worldwide to measure pain intensity. It is rated on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain imaginable.

  during topical and local anesthesia procedure

• SEM (SOUND, EYE, MOTOR) SCALE

  The SEM scale is used to objectively assess anxiety. It evaluates anxiety based on vocalizations, eye signs, and motor movements. Each measure is assigned a score ranging from 1 to 4, where 1 = comfortable and 4 = severe discomfort. The total score ranges from 3 to 12, where 3 = comfortable and 12 = severe discomfort. The total score is calculated as the sum of the three scores assigned for vocalizations, eye signs, and motor movements.

  during topical and local anesthesia procedure

• Finger-Type Pulse Oximeter (heart rate measurement device)

  A finger-type pulse oximeter is a non-invasive method that allows us to assess changes in oxygen saturation in arterial blood through the skin. Using a pulse oximeter, changes in oxygen saturation levels and heart rate can be measured within a short period of time.

  during topical and local anesthesia procedure

Study Arms (5)

Topical Anesthetic Spray

ACTIVE COMPARATOR

Other: Vemcaine

Topical Anesthetic Gel

ACTIVE COMPARATOR

Other: VISION

Ice

ACTIVE COMPARATOR

Other: ICE

Basil Oil

ACTIVE COMPARATOR

Other: Essences and Essential Oils

Chamomile Oil

ACTIVE COMPARATOR

Other: Essences and Essential Oils

Interventions

Vemcaine OTHER

topical anesthetic spray

Topical Anesthetic Spray

Essences and Essential Oils OTHER

topical anesthetic effect of chamomile oil

Chamomile Oil

VISION OTHER

topical anesthetic gel

Topical Anesthetic Gel

ICE OTHER

topical anesthetic effect of ice

Ice

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6-12 years
• Patients requiring buccal infiltration anesthesia in the upper jaw
• Upper jaw teeth requiring restoration that do not exhibit pain, pulpitis, or percussion symptoms and do not have an abscess
• Patients with no open lesions, trauma, etc., in the anesthetic area inside the mouth
• Patients who are willing to participate and have signed an informed consent form
• Patients with no known allergy to topical anesthetic agents or their derivatives
• Patients without systemic disorders or serious mental/psychological disorders -Patients without any allergies (non-atopic)
• Patients who have not taken any medications within the past 24 hours that could affect their pain threshold (e.g., analgesics, anxiolytics, anti-inflammatory drugs)
• Patients scoring 3 or 4 (positive, definitely positive) on the Frankl Behavior Scale.

You may not qualify if:

• Patients younger than 6 years or older than 12 years
• Patients who do not require maxillary buccal infiltration anesthesia
• Patients with maxillary teeth presenting with pain, tenderness to percussion, symptoms of pulpitis, or the presence of an abscess
• Patients with any open lesion, aphthous ulcer, trauma, or similar condition in the intraoral area where anesthesia will be administered
• Patients who are unwilling to participate and do not sign the informed consent form
• Patients with a known allergy to topical anesthetic agents or their derivatives
• Patients with systemic disorders or severe mental/psychological disorders
• Patients with any known allergy (atopic individuals)
• Patients who have used medications within the previous 24 hours that may affect the pain threshold (e.g., analgesics, anxiolytics, or anti-inflammatory drugs)
• Patients with a score of 1 or 2 on the Frankl Behavior Rating Scale (definitely negative or negative).

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak University

Uşak, Merkez, 64000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Oils, Volatile; Vision, Ocular; Ice

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids; Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: September 30, 2026
• Study Start: April 1, 2025
• Primary Completion: June 2, 2025
• Study Completion: October 19, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-08

Locations

TU (1)