Clinical trial NCT05443022: Photobiomodulation on the Salivary Glands of Patients With Xerostomia Induced by the Use of Benzodiazepines
Official title: Effect of Photobiomodulation on the Salivary Glands of Patients With Xerostomia and Hyposalivation Induced by the Use of Benzodiazepines - Study Protocol for a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Xerostomia
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-07-05
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: Depression is the most common mental illness and antidepressants are in the first line of treatment of depressed patients. This therapeutic class is inevitably associated with side effects and adverse reactions, xerostomia being a symptom that seems to be transverse to them all. Saliva performs multiple functions and plays a vital role in protecting the health of the soft and hard tissues of the oral cavity. Reductions in salivary flow are most often manifested as dry mouth, and this is the subjective complaint called xerostomia. Although xerostomia is the most frequent indication of reduced salivary production, it is not invariably associated with hyposalivation. The user of antidepressant drugs has a number of important systemic and oral complications. Treatment for salivary changes remains unknown, but low-level laser therapy has been shown to be effective in improving salivary flow in patients with xerostomia due to diabetes, Sjogren's syndrome, chemotherapy and radiotherapy for head, neck and lung cancer. This randomized controlled trial aims to evaluate oral symptoms related to salivary gland function and mucosal condition of depressed patients, as well as the effects of photobiomodulation on salivary flow. Sixty patients will be included in the protocol, after signing the Informed Consent Form. They will undergo anamnesis, physical evaluation and oral health self-perception questionnaires and symptoms related to salivary gland function and then will be divided into two groups: Photobiomodulation (PBM) (n=30); will have their larger salivary glands irradiated with Diode laser (808nm, 4J per point, 40s) and placebo (PCB) (n=30), which will be subjected to a simulation, where the application protocol will be repeated, but with the laser off. Previous and post treatment sialometries will be performed to compare saliva volume. Biochemical analysis, in which total protein and calcium will be measured, will also be performed.


Eligibility criteria: Inclusion Criteria:

* Participants in good general health, but who have depression with regular use of benzodiazepines;
* Complaints of xerostomia or hyposalivation;
* Over 18 years of age;
* Be able to understand and sign the Informed Consent Form.

Exclusion Criteria:

* Participants who present current acute systemic infectious conditions;
* Chronic kidney disease;
* Diabetics;
* Participants with a history of mental disorders other than depression and anxiety;
* Participants without conditions for dental treatment in the month of referral to the dental service;
* Hemodynamic instability;
* Signs and symptoms related to the cardiovascular systems;
* Acute systemic infectious processes;
* Acute cardiovascular disease;
* Those with any type of photosensitivity;
* Neoplasms in the region of glands;
* Under 18 years of age;
* Pregnant or lactating women;
* Participants with xerostomia not induced by anxiolytics.

Primary outcomes:
measure: Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)
timeFrame: Baseline and immediately after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
state: SP
Study officials:
References: