Evaluation of the Anti-anaesthetic Effects of Low-Level L... | NCT06193460

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

NCT06193460

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Aug 1, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Local Anesthetic Complication

Interventions

low-level laser therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jul 1, 2024Actual

Completion Date

Jul 29, 2024Actual

First Submitted Date

Dec 20, 2023

First Submission Date that Met QC Criteria

Jan 4, 2024

First Posted Date

Jan 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2024

Last Update Posted Date

Aug 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
low-level laser therapy	Device	photobiomodulation mode of diode laser (low-level laser therapy).	laser group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.