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

Effectiveness of Laser Photobiomodulation Therapy in Reducing Child Pain During Local Anesthesia Injection (a Randomized Controlled Clinical Trial)

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

Study Overview

• Status: Recruiting
• Conditions: Local Anesthesia Injection Pain
• Intervention / Treatment: Device: Photobiomodulation; Drug: Benzocaine Gel

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aliaa Hamouda, MSc; Phone Number: +2 010062680616; Email: aliaa.hamouda@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Recruiting
    • Faculty of Dentistry, Alexandria University
    • Contact: Aliaa Hamouda, MSc; Phone Number: +2 01062680616; Email: aliaa.hamouda@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Completion of the written informed consent form by parents/guardian.
• Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
• Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
• Lack of history of allergy to the materials used for anesthesia and sulfite
• Children free of any systemic disease or special health care needs (ASA 1)

Exclusion Criteria:

• Children who receive any analgesic drugs at least 24 hours before treatment.
• Any inflammation or lesion in the injection site
• Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
• Child coming for emergency treatment of pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation	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.
Active Comparator: Topical anesthesia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	A brief demonstration of the pulse oximeter will be performed, and the patient will be instructed to remain still and avoid hand movement in order to obtain accurate readings. The pulse oximeter will be placed on the patient's index finger to measure the baseline heart rate (prior to administering the LA), and another measurement will be taken during the LA administration. Heart rate will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.	during local anesthesia administration
Pain Reaction	The Sound, Eye, Motor (SEM) Scale will be used to assess pain. It encompasses the following parameters: (1) Sound, (2) Eye and (3) Motor. The sounds, eye symptoms and body movements of each child will be independently evaluated by a blind impartial observer using the recorded video tapes. The slightest manifestation of the patient's sound, eyes, or motion is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. The SEM score will be calculated by adding the three parameter grades.	during local anesthesia administration
Perceived Pain	To subjectively record pain during LA injection, a modified face scale will be used. It comprises three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively. Each child will be taught before injection how to use the scale by modelling and then asking each participant to recall the last time she or he felt something painful and select the facial expression that best represented his or her experience of discomfort.	immediately after local anesthesia administration

Collaborators and Investigators

• Sponsor: Aliaa Hamouda
• Investigators: Principal Investigator: Aliaa Hamouda, MSc, Alexandria University; Study Chair: Amani Khalil, PhD, Alexandria University; Study Director: Laila El-Habashy, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Benzocaine
• Other Study ID Numbers: #11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No