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Effect of Photobiomodulation for Patients With Xerostomia (xeros)

Primary Purpose

Photobiomodulation, Low-Level Light Therapy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Low-Level Light Therapy
Sponsored by
Pia Lopez Jornet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photobiomodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lopez-Jornet Pia
  • Pia Lopez Jornet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Low-Level Light Therapy ACTIVE

Low-Level Light Therapy sham

Arm Description

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.

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

Outcomes

Primary Outcome Measures

xerostomia
Comparison of changes in mouth Dryness Score
SIALOMETRY
Sialometry was performed using the passive droll technique.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
April 13, 2022
Sponsor
Pia Lopez Jornet
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1. Study Identification

Unique Protocol Identification Number
NCT05336981
Brief Title
Effect of Photobiomodulation for Patients With Xerostomia
Acronym
xeros
Official Title
Effect of Photobiomodulation for Patients With Xerostomia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pia Lopez Jornet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photobiomodulation, Low-Level Light Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Level Light Therapy ACTIVE
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-Level Light Therapy sham
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Low-Level Light Therapy
Intervention Description
The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular
Primary Outcome Measure Information:
Title
xerostomia
Description
Comparison of changes in mouth Dryness Score
Time Frame
Change (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 days
Title
SIALOMETRY
Description
Sialometry was performed using the passive droll technique.
Time Frame
before and after 45 days the procedure of laser therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Lopez Jornet
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lopez-Jornet Pia
City
Murcia
State/Province
N/A = Not Applicable
ZIP/Postal Code
30008
Country
Spain
Facility Name
Pia Lopez Jornet
City
Murcia
ZIP/Postal Code
30004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31873066
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.
Results Reference
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PubMed Identifier
29022754
Citation
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.
Results Reference
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Effect of Photobiomodulation for Patients With Xerostomia

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