Effect of Photobiomodulation for Patients With Xerostomia
xeros
1 other identifier
interventional
60
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedApril 20, 2022
April 1, 2022
1 year
April 5, 2022
April 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
SIALOMETRY
Sialometry was performed using the passive droll technique.
before and after 45 days the procedure of laser therapy
Study Arms (2)
Low-Level Light Therapy ACTIVE
EXPERIMENTALPatients 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.
Low-Level Light Therapy sham
SHAM COMPARATORPatients 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
Interventions
The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pia Lopez Jornetlead
Study Sites (2)
Lopez-Jornet Pia
Murcia, N/A = Not Applicable, 30008, Spain
Pia Lopez Jornet
Murcia, 30004, Spain
Related Publications (2)
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.
PMID: 31873066BACKGROUNDBrzak 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.
PMID: 29022754BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pia Lopez Jornet
Universidad de Murcia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head Oral Medicine
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 20, 2022
Study Start
January 1, 2020
Primary Completion
January 1, 2021
Study Completion
January 26, 2022
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share