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Effectiveness of Laser Photobiomodulation Therapy in Reducing Child Pain During Local Anesthesia Injection

NCT05861154 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-05-16

No results posted yet for this study

Summary

This study aimed to evaluate the impact of laser photobiomodulation therapy used as pre-anesthetic technique to reduce child pain during local anesthesia administration

Conditions

  • Local Anesthesia Injection Pain

Interventions

DEVICE

Photobiomodulation

A diode laser (Sirolaser blue laser system, Sirona Dental Systems GmbH, Fabrikstraße 31, 64625 Bensheim, Germany) of Wavelength 660 nm will be used and the laser parameters will be set as follows: Power 0.1 W, energy 6 J, Continuous wave, Irradiation time 60 Seconds; energy Tip area 0.5 cm2, fluence 12 J/cm2 will be applied at the site of needle penetration. It should be noted that before each application, the output of the laser device will be checked using the aiming beam on flat surface; both the patient and the operator will wear safety goggles during the irradiation.

DRUG

Benzocaine Gel

a 20% Benzocaine topical anaesthetic gel will be applied. To increase the absorption of the topical anaesthetic gel, soft tissues will be dried with (2 x 2 cm) gauze. Topical anaesthetic gel will be applied at the site of needle penetration and left in contact with the soft tissues for one minute in order to to maximize its effect.

Sponsors & Collaborators

  • Aliaa Hamouda

    lead OTHER

Principal Investigators

  • Aliaa Hamouda, MSc · Alexandria University

  • Amani Khalil, PhD · Alexandria University

  • Laila El-Habashy, PhD · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05861154 on ClinicalTrials.gov