Clinical trial
The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19. A Randomized Controlled Trial.
Name
Covidlongasusy
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2024-02-01
Trial end
2024-03-08
Status
Completed
Phase
Early phase I
Treatment
Institutional standard treatment for xerostomia and Long Covid
(Medical follow-up at the general outpatient clinic for prescription and control of medications, underlying diseases, clinical status and routine short, medium and long-term care follow-up, standard guidelines for the use of aerobic physical activity in those who do not have contraindications, stretching exercises, ergonomics, home adaptation to maximize functionality and energy savings, emotional cognitive support psychotherapy, socio-educational measures, sleep hygiene, Nutritional follow-up and monitoring, dentistry follow-up at the University's odontological team, guidance on proper oral hygiene, use of low-sugar diets, daily topical use of fluoride and antimicrobial mouthwash to prevent dental caries, oral hydration, guidance on avoiding cigarette use or intake of caffeine-containing beverages . When necessary, measures such as oral lubricants, artificial saliva, measures to prevent aspirations, as well as the careful use of liquids during meals, can be instituted ) +
Arms:
Photobiomodulation Therapy, Placebo Photobiomodulation
Photobiomodulation Therapy
Application of Red LED in the 3 pairs of major salivary glands (parotid, submandibular and sublingual) extraorally, transcutaneously, for 36 seconds, twice a week for 06 weeks.
Arms:
Photobiomodulation Therapy
Other names:
PBM therapy
Placebo Photobiomodulation Therapy
All parameters as the number of points, dose and place of application of the PBM will be the same as described in the item PBM therapy Intervention Group, however in the placebo PBM equipment will be turned off. The device activation noise will be recorded and used to mimic the irradiation.
Arms:
Placebo Photobiomodulation
Size
10
Primary endpoint
Brazilian version of the SF 36 Quality of Life Scale
pre-treatment and post-treatment moment (after 04 weeks of treatment)
Nutritional assessment
pre-treatment and post-treatment (after 04 weeks of treatment)
Salivary ph, Stimulated salivary flow and unstimulated salivary flow
pre-treatment and post-treatment (after 04 weeks of treatment)
Oral Health Impact Profile (OHIP-14)
pre-treatment and post-treatment (after 04 weeks of treatment)
Xerostomia Inventory XI
pre-treatment and post-treatment (after 04 weeks of treatment)
Functional Independence Measure (FIM)
pre-treatment and post-treatment (after 04 weeks of treatment)
Post-Covid-19 Functional Status Scale
pre-treatment and post-treatment (after 04 weeks of treatment)
The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
pre-treatment and post-treatment (after 04 weeks of treatment)
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2024-03-12
1 organization
Organization
University of Nove de Julho