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

Not Applicable

Recruiting

• Conditions: Local Anesthesia Injection Pain
• Interventions: Device: Photobiomodulation; Drug: Benzocaine Gel

• Registration Number: NCT05861154
• Lead Sponsor: Aliaa Hamouda

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-04-28
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-14
• Last Update Submitted: 2023-05-14
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation	Photobiomodulation	-
Topical anesthesia	Benzocaine Gel	-

Primary Outcome Measures

Name	Time	Method
Heart Rate	during local anesthesia administration	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.
Pain Reaction	during local anesthesia administration	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.
Perceived Pain	immediately after local anesthesia administration	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt