The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19.A Randomized Controlled Trial.

ABSTRACT

ConditionXerostomia;COVID-19;Long COVID;Persistent COVID-19

InterventionCombination Product Institutional standard treatment for xerostomia and Long Covid;Radiation Photobiomodulation Therapy;Radiation Placebo Photobiomodulation Therapy

Primary outcome:Brazilian version of the SF 36 Quality of Life Scale;Nutritional assessment;Salivary ph, Stimulated salivary flow and unstimulated salivary flow;Oral Health Impact Profile (OHIP-14);Xerostomia Inventory XI;Functional Independence Measure (FIM);Post-Covid-19 Functional Status Scale;The World Health Organization Disability Assessment Schedule (WHODAS 2.0)

Criteria
Inclusion Criteria

- Clinical diagnosis xerostomia related to Long-COVID;

- more than 4 weeks after the acute infection hat have persisted for at least 02 months
(regardless of whether these patients are already using treatment for the complaints
or not);

- Age greater than 18 years.

Exclusion Criteria

- Clinical diagnosis of other previous rheumatological or musculoskeletal diseases that
presents xerostomia;

- Previous use in the last 90 days of laser treatment or other photobiomodulation
technique for the same or another indication;

- Clinical manifestations or complaints of xerostomia related to diseases other than
Long COVID;

- Previous diseases of the oral or nasal cavity that occur with the symptom of
xerostomia;

- Systemic inflammatory diseases (rheumatoid arthritis, Reiter's arthritis, ankylosing
spondylitis, generalized polyarthritis, neoplasms);

- Uncontrolled metabolic or endocrine diseases;

- Neoplastic diseases;

- Serious cognitive or psychiatric disorders that that do not allow the understanding of
the study;

- Steroid injections during the last 48 hours prior to baseline study assessment;

- Use of corticosteroids at an immunosuppressive dose (20mg daily of prednisone or
equivalent for at least 14 days);

- Infection or tumor at the site of therapy application;

- Current chronic infections such as tuberculosis or chronic hepatitis treated or not;

- Severe blood dyscrasia;

- Blood clotting disorders (including thrombosis) at the application site;

- Psychoaffective disorder that prevents adherence to treatment;

- Signs, symptoms or laboratory changes suggestive of acute reinfection by COVID 19;

- Elevated resting heart rate (>100 beats/min);

- Low or high blood pressure (<90/60 or >140/90 mmHg);

- Low blood oxygen saturation (<95%) at rest, or dyspnea grade 3, 4, or 5 on the Medical
Research Council Dyspnea Scale (KOVELIS et al., 2008), or exacerbation of dyspnea on
exertion;

- Any condition where exercise is a contraindication such as decompensated heart
disease, decompensated diabetes;

- Contraindications to the rehabilitation treatment of post-COVID syndrome recommended
by the WHO presence of heart disease after acute COVID, decrease in blood oxygen
saturation after exercise (below 94% or decrease of at least 3% of the baseline
saturation), presence of orthostatic hypotension;

- Any photosensitive disease or light sensitivity condition;

- Loss of follow-up at the follow-up clinical outpatient clinic, despite maintaining use
of PBM according to the study protocol;

- Pregnancy;

- Any adverse effect on the previous use of PBM.