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

Local Anesthetic Complication Clinical Trial

— laser  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06193460
• Other study ID #: ODHOD-101-1Q
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: Al-Azhar University
• Contact: Alaa Eldehna, M.D
• Phone: +201068837641
• Email: alaaaldehna.26[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Local Anesthetic Complication

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcomes measuring the duration (in minutes) of anaesthesia withdrawal after laser application	Return the normal sensation to the lip.; Being able to smile, drink, and talk normally.; Return of pain sensation that result from the procedure	after application of laser immediately and continue each 15 minutes till complete withdrawal of anaesthesia