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

NCT05861154 | Unknown

• 1 other identifier: #11
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

Device: Photobiomodulation

Topical anesthesia

ACTIVE COMPARATOR

Drug: Benzocaine Gel

Interventions

Photobiomodulation DEVICE

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.

Photobiomodulation

Benzocaine Gel DRUG

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.

Topical anesthesia

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aliaa Hamouda: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

RECRUITING

Related Publications (1)

• Hamouda AA, El-Habashy LM, Khalil A. The use of laser photobiomodulation as pre-anesthetic tissue management technique in reducing injection pain in children. BMC Oral Health. 2024 Jun 22;24(1):717. doi: 10.1186/s12903-024-04430-3.

  PMID: 38909229 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Aliaa Hamouda, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Amani Khalil, PhD

  Alexandria University

  STUDY CHAIR

• Laila El-Habashy, PhD

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Aliaa Hamouda, MSc

CONTACT

010062680616; aliaa.hamouda@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatric Dentistry

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 16, 2023
• Study Start: December 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

EG (1)