The Management of RT-induced Hyposalivation Using LLLT

NCT05538169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-23

No results posted yet for this study

Summary

The primary purpose is to evaluate the effectiveness of photobiomodulation laser application in the management of patients with radiotherapy-induced hyposalivation. Secondary, to assess the changes in the scores of the patient's oral health-related quality of life using validated measurements.

Conditions

Interventions

DEVICE

low-level laser diode (Pioon Laser)

Settings: the spot tip area of this tool is 0.088 cm2, semi-conductor diode, with a wavelength of 980 nm (near infrared), 200 mW output power, 1.97W/cm2 of power density, 3 J energy per point and application time 15 seconds per point\]. * PBM will apply punctually, in continuous emissions. * Extra-oral points: six points on each parotid gland, three points on each submandibular gland. * Intra-oral points: two points on each sublingual gland. * A total of 22 points will be applied in each session.

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2023-08-01
Completion
2023-10-01

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05538169 on ClinicalTrials.gov