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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Local Anesthesia Injection Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Photobiomodulation

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type 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.

Topical anesthesia

Group Type ACTIVE_COMPARATOR

Benzocaine Gel

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No