Effect of Photobiomodulation for Patients With Xerostomia

Photobiomodulation Clinical Trial

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Official title:

Effect of Photobiomodulation for Patients With Xerostomia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336981
• Other study ID #: University Murcia 1229/2015
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 26, 2022

Study information

• Verified date: April 2022
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 26, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Low-Level Light Therapy
• Photobiomodulation
• Xerostomia

Intervention

Radiation:
• Low-Level Light Therapy
The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular

Locations

Country	Name	City	State
Spain	Lopez-Jornet Pia	Murcia	N/A = Not Applicable
Spain	Pia Lopez Jornet	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Pia Lopez Jornet

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Brzak BL, Cigic L, Baricevic M, Sabol I, Mravak-Stipetic M, Risovic D. Different Protocols of Photobiomodulation Therapy of Hyposalivation. Photomed Laser Surg. 2018 Feb;36(2):78-82. doi: 10.1089/pho.2017.4325. Epub 2017 Oct 12. — View Citation

Kalhori KAM, Vahdatinia F, Jamalpour MR, Vescovi P, Fornaini C, Merigo E, Fekrazad R. Photobiomodulation in Oral Medicine. Photobiomodul Photomed Laser Surg. 2019 Dec;37(12):837-861. doi: 10.1089/photob.2019.4706. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	xerostomia	Comparison of changes in mouth Dryness Score	Change (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 days
Primary	SIALOMETRY	Sialometry was performed using the passive droll technique.	before and after 45 days the procedure of laser therapy