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Effect of Photobiomodulation for Patients With Xerostomia

Effect of Photobiomodulation for Patients With Xerostomia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05336981
Acronym
xeros
Enrollment
60
Registered
2022-04-20
Start date
2020-01-01
Completion date
2022-01-26
Last updated
2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-Level Light Therapy, Photobiomodulation

Brief summary

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

Detailed 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).

Interventions

RADIATIONLow-Level Light Therapy

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

Sponsors

Pia Lopez Jornet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
xerostomiaChange (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 daysComparison of changes in mouth Dryness Score
SIALOMETRYbefore and after 45 days the procedure of laser therapySialometry was performed using the passive droll technique.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026