Photobiomodulation in Salivary Production of Patients With Xerostomy

University of Nove de Julho

Status and phase: Unknown; Phase 2

Conditions: Xerostomia

Treatments: Radiation: Photobiomodulation; Radiation: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT03632096

Malu

Details and patient eligibility

About

Xerostomia is a quantitative and qualitative alteration of saliva, a symptom present in individuals who make continuous use of medications to control chronic diseases, including hypertension. Difficulties in mastication, swallowing, phonation and palate are present, besides oral burning syndrome, periodontal disease, root caries and bad breath that will interfere in the quality of life, making it difficult to socialize in society. Currently, the methods presented for treatment of xerostomia are palliative, so their use does not consist of an effective treatment. The objective of this study is to evaluate the efficacy of photobiomodulation in the production of saliva in patients with xerostomia induced by antihypertensive drugs. The method consists in the application of the low intensity laser in the three pairs of salivary glands - parotid, submandibular and sublingual. The parameters that will be used are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2. The control group will have a simulation of the application of the laser, with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off. In the group that receives the photobiomodulation the device will have its timer turned off, to avoid the perception of sound difference. At the end of the sessions, a sample of saliva will be collected, which will be compared to the initial sample.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertensive patients using antihypertensive drugs who present xerostomia;
• Hospitalized in the high-stay unit of the Mandaqui Hospital Complex;
• Patients who sign the free and informed consent form.

Exclusion criteria

• Patients with cancer in the oral region;
• Patients receiving radiation therapy;
• Patients with Sjögren's Syndrome;
• Diabetics and those with any type of photosensitivity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Photobiomodulation group

Active Comparator group

Description:

Patients will receive 3 applications of low intensity light directly in the region of the three pairs of salivary glands already described. The ArGaAl diode laser, DMC 808nm 4J/point equipment will be used. The parameters that will be used are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2. The first application will be after the stimulated collection of saliva and the following applications will be given once a week for another 2 weeks.

Treatment:

Radiation: Photobiomodulation

Sham group

Sham Comparator group

Description:

The placebo group will have a simulation of application of the laser, following the same technique as the active group, but with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off.

Treatment:

Radiation: Sham