Effect of Photobiomodulation for Patients With Xerostomia (xeros)

Pia Lopez Jornet

Status: Completed

Conditions: Photobiomodulation; Low-Level Light Therapy

Treatments: Radiation: Low-Level Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05336981

University Murcia 1229/2015

Details and patient eligibility

About

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

Full description

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Low-Level Light Therapy ACTIVE

Experimental group

Description:

Patients will receive applications of photobiomodulation directly in the region extraoral of the salivary glands ( parotid and submaxilar) will be given once a week for another 6 weeks.

Treatment:

Radiation: Low-Level Light Therapy

Low-Level Light Therapy sham

Sham Comparator group

Description:

Patients will receive applications of photobiomodulation sham directly in the region extraoral of the salivary glands ( parotid and submaxilar) will be given once a week for another 6 weeks

Treatment:

Radiation: Low-Level Light Therapy