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NCT Number: NCT06193460

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

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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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university

Cairo, Egypt

About this study

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Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

Patients who are mentally disordered or hand-capped. uncooperative patients.

Treatment and study plan

Low-Level Laser Therapy

Device

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

Primary outcomes

  1. Outcomes measuring the duration (in minutes) of anaesthesia withdrawal after laser application

    Time frame: after application of laser immediately and continue each 15 minutes till complete withdrawal of anaesthesia

    • Return the normal sensation to the lip.
    • Being able to smile, drink, and talk normally.
    • Return of pain sensation that result from the procedure

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: laser

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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