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
About this trial
This is an interventional treatment trial for Photobiomodulation
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
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
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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Learn more about this trial
Effect of Photobiomodulation for Patients With Xerostomia
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