Effect of Photobiomodulation for Patients With Xerostomia

Not Applicable

Completed

• Conditions: Photobiomodulation; Low-Level Light Therapy
• Interventions: Radiation: Low-Level Light Therapy

• Registration Number: NCT05336981
• Lead Sponsor: Pia Lopez Jornet

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).

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2022-01-26
• Status Verified: 2022-04
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Level Light Therapy sham	Low-Level Light Therapy	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
Low-Level Light Therapy ACTIVE	Low-Level Light Therapy	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.

Primary Outcome Measures

Name	Time	Method
xerostomia	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
SIALOMETRY	before and after 45 days the procedure of laser therapy	Sialometry was performed using the passive droll technique.

Trial Locations

Locations (2)

Pia Lopez Jornet; 🇪🇸 Murcia, Spain

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