NCT05760092CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 12 Mar 2024

Brief summary (registry, in English)

Coronavirus (COVID-19) is a newly emerging zoonotic agent that emerged in December 2019 in China (2019-nCoV) as a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV -2). Long COVID-19, or Post-Covid Syndrome or Long-term COVID-19, is a post-viral syndrome that persists after the acute infection has resolved. The most frequent symptoms of Lonf-term COVID are fatigue and dyspnea. But two classes of symptoms have been received scientific attention: the musculoskeletal pain and oral complaints related to Long COVID, mainly xerostomia and burning mouth. Photobiomodulation (PBM) therapy is often used for oral diseases and presents itself as a non-invasive, low-cost, safe therapy that has benefits in relation to the quality of life of patients with xerostomia. This study aims to investigate the clinical effectiveness of the use of a Photobiomodulation protocol in the treatment xerostomia and oral complaints related to Long-Covid. This will be a single-center, randomized, controlled, blinded clinical trial that will involve patients with Long COVID in follow-up at the Medical and Multiprofessional outpatient clinic of University Nove de Julho (UNINOVE) which remained hospitalized with COVID-19 at Lydia Storópoli Universitarian Hospital during the year 2022 and who were discharged from the inpatient treatment from January to December 2022. All those patients presenting xerostomia, burning mouth or oral complaints related to Long Covid will be randomized into 2 groups: PBM Group (standard rehabilitation treatment for Long COVID and xerostomia + PBM therapy) or PBM placebo group (standard rehabilitation treatment for Long COVID and xerostomia + placebo PBM therapy). PBM consists of the application of Red LED on the 3 pairs of major salivary glands (parotid, submandibular and sublingual) extraorally, transcutaneously, 3 J/cm2, for 36 seconds, twice a week for 06 weeks. Functional and quality of life evaluations will be perform pre and post therapy period.

Status (registry): Completed
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 10 (actual)
First submitted: 20 Sept 2022
Start date: 1 Mar 2023
Primary completion date: 1 Feb 2024
Lead sponsor: University of Nove de Julho
Diseases: Long COVID and ME/CFS
NCT number: NCT05760092

What you commit to

Study type: Interventional · Phase 2
Participants enrolled: 10
From 1 Mar 2023 to the primary completion date, 1 Feb 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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;
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);
Any adverse effect on the previous use of PBM.

Other illness

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;
Infection or tumor at the site of therapy application;
Current chronic infections such as tuberculosis or chronic hepatitis treated or not;
Blood clotting disorders (including thrombosis) at the application site;
Psychoaffective disorder that prevents adherence to treatment;
Elevated resting heart rate (\>100 beats/min);
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;

Lab values

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

Other

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

Who the study is looking for

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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences Coordinator of this site? Confirm its status	São Paulo	Brazil	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.