NCT06193460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

December 20, 2023

Last Update Submit

July 31, 2024

Conditions

Local Anesthetic Complication

Outcome Measures

Primary Outcomes (1)

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

    1. Return the normal sensation to the lip. 2. Being able to smile, drink, and talk normally. 3. Return of pain sensation that result from the procedure

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

Study Arms (2)

laser group

EXPERIMENTAL

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

Device: low-level laser therapy

control group

NO INTERVENTION

The anesthesia will be withdrawn without intervention.

Interventions

low-level laser therapyDEVICE

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

laser group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university

Cairo, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of paediatric dentistry

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 5, 2024

Study Start

January 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 29, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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. Laser Group: (20 teeth) The anaesthesia will be reversed by the photobiomodulation mode of the diode laser (low-level laser therapy). Controlled Group: (20 teeth) anaesthesia will be withdrawn without intervention.

Locations

EG(1)