Transcutaneous Photobiomodulation on the Control of Chilhood Anxiety in Dental Care.

NCT05549128 | Unknown

• 1 other identifier: TPMBAnx
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to investigate whether photobiomodulation helps, collaborates, in the management of the child's anxiety in the dental office.

Conditions

Anxiety

Keywords

anxiety; photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Facial Image Scale (FIS) in the conditioned room prior to dental care.

  30 minutes

Secondary Outcomes (1)

• heart rate

  30 minutes

Study Arms (2)

photobiomodulation

EXPERIMENTAL

laser therapy application for 10 minutes

Device: Photobiomodulation

Sham photobiomodulation

SHAM COMPARATOR

sham laser therapy application for 10 minutes

Device: Photobiomodulation sham

Interventions

Photobiomodulation DEVICE

The red laser (DMC) will be applied with the aim of reducing the anxiety of children during the dental consultation. It will be continuously and directly with 60J of energy, wavelength of 660nm and 100mW/cm2 of power. The application will be located in the unilateral radial artery for 10 minutes. The laser will be transmitted through an appropriate bracelet where the laser tip fits perfectly. It is a painless, non-invasive method that does not cause any discomfort during application.

photobiomodulation

Photobiomodulation sham DEVICE

The red laser (DMC) will be applied off. I

Sham photobiomodulation

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 6 and 12 years old. Children who do not consume oral anxiolytics. Children who need dental treatment. Children whose responsible adults have accepted informed consent. Children who have signed a nod of care.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Lara RENE Motta, PhD

CONTACT

11998829511; larajmotta@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be performed for the application of the ILIB during the clinical session. An operator will be trained who will be the one who will perform the application. Another operator, in this case the researcher (blind), will be in charge of collecting the parameters to be evaluated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 2 groups: experimental group (G1), control group or placebo (G2) where ILIB and placebo will be applied respectively.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 22, 2022
• Study Start: November 10, 2022
• Primary Completion: November 10, 2023
• Study Completion: March 20, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share