Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT06193460
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2023-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Anti-anaesthetic Effects of Low-Level Laser Therapy on Children's Soft Tissue
Sponsor:
Al-Azhar University
Organization:
Study Overview
Official Title:
Evaluation of the Anti-anaesthetic Effects of Low-Level Laser Therapy on Children's Soft Tissue Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
laser
Brief 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.
Detailed 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Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.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).
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Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: