Photobiomodulation on the Salivary Glands of Patients With Xerostomia Induced by the Use of Benzodiazepines

NCT ID: NCT05443022

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2023-06-20

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.

Conditions

Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Photobiomodulation group

Participants in this group will have their larger salivary glands irradiated with diode laser.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation

Intervention Type: RADIATION

Participants will receive an application of low intensity light directly in the region of the three pairs of salivary glands. 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.

Placebo group

Participants in this group will be subjected to a simulation, where the application protocol will be repeated, but with the laser turned off.

Group Type: PLACEBO_COMPARATOR

Simulation of Photobiomodulation

Intervention Type: RADIATION

The placebo group will have a simulation of the 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.

Interventions

Photobiomodulation

Participants will receive an application of low intensity light directly in the region of the three pairs of salivary glands. 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.

Intervention Type: RADIATION

Simulation of Photobiomodulation

The placebo group will have a simulation of the 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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nove de Julho University

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Sandra K Bussadori, PhD

Role: CONTACT

sandra.skb@gmail.com

+55 11 2633-9000

Facility Contacts

Sandra K Bussadori, PhD

Role: primary

sandra.skb@gmail.com

+55 11 2633-9000

Other Identifiers

Cícero

Identifier Type: -

Identifier Source: org_study_id