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OpenTrials
Completed

NCT Number: NCT05336981

Effect of Photobiomodulation for Patients With Xerostomia

Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life.

The aim of the present study was analized the effects of low-level light therapy irradiation (photobiomodulation PBM) on salivary gland function in patients with hyposalivation

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Key information

Conditions

Photobiomodulation Low-Level Light Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lopez-Jornet Pia, Murcia, N/A = Not Applicable, Spain

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About this study

Inclusion criteria

-the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow < 0.1 mL/min).

Exclusion criteria

. : xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems

The 60 individuals will be randomized in 2 groups: Group A (30 individuals submitted to treatment with a PBM) and Group B (30 individuals submitted to simulated PBM). A total of 60 patients with xerostomia were enrolled in the study and cited once a week for a period of 6 weeks treatment with diode laser (810nm, 6J/cm2) or sham treatment (according to the group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow < 0.1 mL/min).

Exclusion criteria

  • The exclusion criteria were: xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems

Treatment and study plan

Low-Level Light Therapy

Radiation

The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular

Primary outcomes

  1. xerostomia

    Time frame: Change (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 days

    Comparison of changes in mouth Dryness Score

  2. SIALOMETRY

    Time frame: before and after 45 days the procedure of laser therapy

    Sialometry was performed using the passive droll technique.

Sponsors and collaborators

Lead sponsor

Pia Lopez Jornet

Other

Registry information

Acronym: xeros

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 20, 2022
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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