Evaluation of the Anti-anaesthetic Effects of Low-Level Laser Therapy on Children's Soft Tissue

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-07-29

Brief Summary

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Evaluate the effect of the photobiomodulation mode of the diode laser on the anaesthetic area and find the best parameter that would accelerate the withdrawal of anaesthesia.

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Detailed Description

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A randomized clinical trial will be performed at the Pedodontics Out Paediatric Clinic at the Facility of Dental Medical for girls. Al Azhar University has twenty patients with upper or lower first primary molars on the right and left sides that need to be treated. Using the split-mouth technique, the mouth will be split in two halves. The first half represents the first group, and the second half represents the second group.

Group I (20 teeth): the anaesthesia will be reversed by the photobiomodulation mode of diode laser (low-level laser therapy).

Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.

To avoid bias in the 2nd group, the laser will be applied on this side, but in turned-off mode. The type of anaesthesia that will be evaluated is articine hydrochloride 4% with 1:200 epinephrine (vasoconstrictor).

Conditions

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Local Anesthetic Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Group I (20 teeth): the anaesthesia will be reversed by the photobiomodulation mode of diode laser therapy (low-level laser therapy).

Group II (controlled group) :( 20 teeth) anaesthesia will be withdraw without intervention.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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laser group

The anaesthesia will be reversed by the photobiomodulation mode of the diode laser (low-level laser therapy).

Group Type EXPERIMENTAL

low-level laser therapy

Intervention Type DEVICE

photobiomodulation mode of diode laser (low-level laser therapy).

control group

The anesthesia will be withdrawn without intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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low-level laser therapy

photobiomodulation mode of diode laser (low-level laser therapy).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Parents have to complete the written consent form. Patient who behaved well. Children aged from 6 to 12 years can evaluate soft tissue anaesthesia. Patients that require treatment with bilateral upper or lower first primary molar infiltration under anaesthesia.