Effect of Photobiomodulation for Patients With Xerostomia

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Photobiomodulation for Patients With Xerostomia

Conditions
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Photobiomodulation, Low-Level Light Therapy

Intervention / Treatment
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* Radiation: Low-Level Light Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Level Light Therapy ACTIVE<br>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<br>* The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular<br>|
| Sham Comparator: Low-Level Light Therapy sham<br>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<br>* The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |