Clinical trial NCT03632096: Photobiomodulation in Salivary Production of Patients With Xerostomy
Official title: Evaluation of Photobiomodulation in Salivary Production of Patients With Xerostomy Induced by Anti-hypertensive Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Xerostomia
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)
timeFrame: One month.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UniNove
state: SP
Study officials:
References:
citation: Varellis MLZ, Goncalves MLL, Pavesi VCS, Horliana ACRT, de Fatima Teixeira da Silva D, Motta LJ, Barbosa Filho VF, Bezerra CDS, Silva FGD, Bussadori SK, Deana AM. Evaluation of photobiomodulation in salivary production of patients with xerostomy induced by anti-hypertensive drugs: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Apr;99(16):e19583. doi: 10.1097/MD.0000000000019583.