Clinical trial

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

Name

#11

Description

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

Trial arms

Trial start

2022-12-01

Estimated PCD

2023-07-01

Trial end

2023-07-01

Status

Recruiting

Treatment

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.

Arms:

Photobiomodulation

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.

Arms:

Topical anesthesia

Size

Primary endpoint

Heart Rate

during local anesthesia administration

Pain Reaction

during local anesthesia administration

Perceived Pain

immediately after local anesthesia administration

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}

Updated at

2023-05-16

1 organization

1 product

1 indication

Organization

Aliaa Hamouda

Product

Benzocaine

Indication

Local Anesthesia Injection Pain