Effect of Photobiomodulation for Patients With Xerostomia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Salivary Markers in Patients With Xerostomia

NCT03156569

Xerostomia Due to Hyposecretion of Salivary Gland

COMPLETED

Photobiomodulation in Salivary Production of Patients With Xerostomy

NCT03632096

Xerostomia

UNKNOWN PHASE2

Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients

NCT06703372

Xerostomia Diabetes Mellitus

COMPLETED NA

Photobiomodulation on the Salivary Glands of Patients With Xerostomia Induced by the Use of Benzodiazepines

NCT05443022

Xerostomia

UNKNOWN PHASE1/PHASE2

Interest of the Sialendoscopy Associated With a Local Injection of Corticosteroids in the Treatment of Radio-induced Xerostomia in Comparison With the Hygiene Rules

NCT04584164

Xerostomia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Photobiomodulation Low-Level Light Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-Level Light Therapy ACTIVE

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.

Group Type EXPERIMENTAL

Low-Level Light Therapy

Intervention Type RADIATION

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

Low-Level Light Therapy sham

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

Group Type SHAM_COMPARATOR

Low-Level Light Therapy

Intervention Type RADIATION

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low-Level Light Therapy

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

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No