xeros: Effect of Photobiomodulation for Patients With Xerostomia

Sponsor

Pia Lopez Jornet (Other)

Overall Status

Completed

CT.gov ID

NCT05336981

Collaborator

(none)

Enrollment

Locations

Arms

24.8

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Photobiomodulation Low-Level Light Therapy	Radiation: Low-Level Light Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Photobiomodulation for Patients With Xerostomia

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Radiation: Low-Level Light Therapy The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular
Sham Comparator: 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	Radiation: Low-Level Light Therapy The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular

Arm

Intervention/Treatment

Experimental: 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.

Radiation: Low-Level Light Therapy

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

Sham Comparator: 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

Radiation: Low-Level Light Therapy

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lopez-Jornet Pia	Murcia	N/A = Not Applicable	Spain	30008
2	Pia Lopez Jornet	Murcia		Spain	30004

Sponsors and Collaborators

Pia Lopez Jornet

Investigators

Principal Investigator: Pia Lopez Jornet, Universidad de Murcia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Pia Lopez Jornet, Head Oral Medicine, Universidad de Murcia

ClinicalTrials.gov Identifier:

NCT05336981

Other Study ID Numbers:

University Murcia 1229/2015

First Posted:

Apr 20, 2022

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Xerostomia

Study Results

No Results Posted as of Apr 20, 2022