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

NCT05760092 | Completed Phase 2

• 1 other identifier: Covidlongasusy
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Xerostomia; COVID-19; Long COVID; Persistent COVID-19

Keywords

Xerostomia; Dry Mouth; COVID-19; Long Covid; Photobiomodulation

Outcome Measures

Primary Outcomes (8)

• Brazilian version of the SF 36 Quality of Life Scale

  Assessment of general quality of life, translated and validated for the Brazilian population, composed of assessments in the following domains: functional capacity, limitation due to physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health.

  pre-treatment and post-treatment moment (after 04 weeks of treatment)

• Nutritional assessment

  Anthropometric measurements of body weight, height and calculation of the Body Mass Index (BMI) according to the World Health Organization (WHO) reference standard for adults and Lipschitz criterion for elderly patients.

  pre-treatment and post-treatment (after 04 weeks of treatment)

• Salivary ph, Stimulated salivary flow and unstimulated salivary flow

  Total salivary flow rates (SFRs) at rest and during stimulation will be determined according to the guidelines for unstimulated and stimulated total saliva collection provided by Navazesh and Kumar (1993). To characterize hyposalivation, investigators will use the Sreebny criterion (2000) according to which the abnormal salivary flow is lower than 0.1 ml/min without stimulation and 0.5 ml/min with stimulation. Salivary pH (unstimulated salivary flow) will also be evaluated, which will be performed using pH indicator paper tape, color scale ranging from 0.0 to 14.0 (gradation 1.0; precision 0.2) The strips will be dipped in samples of saliva for 5 min. Then the test fields of the strips will be compared with the color scales. Whereas healthy saliva must have a pH between 6.5 to 7.4.

  pre-treatment and post-treatment (after 04 weeks of treatment)

• Oral Health Impact Profile (OHIP-14)

  Assessment of Oral Health-related Quality of Life, by OHIP-14 , translated and validated for Brazilian population

  pre-treatment and post-treatment (after 04 weeks of treatment)

• Xerostomia Inventory XI

  A multi-item approach to measuring and quantify dry mouth.

  pre-treatment and post-treatment (after 04 weeks of treatment)

• Functional Independence Measure (FIM)

  A translated and validated for the Brazilian population of general assessment of functional independence

  pre-treatment and post-treatment (after 04 weeks of treatment)

• Post-Covid-19 Functional Status Scale

  A tool to measure the full spectrum of functional outcomes following COVID-19.

  pre-treatment and post-treatment (after 04 weeks of treatment)

• The World Health Organization Disability Assessment Schedule (WHODAS 2.0)

  The World Health Organization Disability Assessment Schedule (WHODAS 2.0) was designed to assess the functioning level in six life domains (cognition, mobility, selfcare, getting along, life activities, and participation in community activities)

  pre-treatment and post-treatment (after 04 weeks of treatment)

Study Arms (2)

Photobiomodulation Therapy

EXPERIMENTAL

Institutional standard treatment for xerostomia and COVID Longa + PBM therapy

Combination Product: Institutional standard treatment for xerostomia and Long Covid; Radiation: Photobiomodulation Therapy

Placebo Photobiomodulation

PLACEBO COMPARATOR

Institutional standard treatment for xerostomia and COVID Longa + PBM placebo therapy

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

Interventions

Institutional standard treatment for xerostomia and Long Covid COMBINATION_PRODUCT

(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 ) +

Photobiomodulation Therapy; Placebo Photobiomodulation

Photobiomodulation Therapy RADIATION

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.

Also known as: PBM therapy

Photobiomodulation Therapy

Placebo Photobiomodulation Therapy RADIATION

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.

Placebo Photobiomodulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences

São Paulo, Brazil

Location

Related Publications (2)

• Chowdhury F, Grigoriadou S, Bombardieri M. Severity of COVID-19 infection in primary Sjogren's syndrome and the emerging evidence of COVID-19-induced xerostomia. Clin Exp Rheumatol. 2021 Nov-Dec;39 Suppl 133(6):215-222. doi: 10.55563/clinexprheumatol/k7x3ta. Epub 2021 Dec 16.

  PMID: 34919045 BACKGROUND

• Verma H, Shah J, Akhilesh K, Shukla B. Patients' perspective about speech, swallowing and hearing status post-SARS-CoV-2 (COVID-19) recovery: E-survey. Eur Arch Otorhinolaryngol. 2022 May;279(5):2523-2532. doi: 10.1007/s00405-021-07217-2. Epub 2022 Jan 21.

  PMID: 35059791 RESULT

MeSH Terms

Conditions

Xerostomia; COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Rebeca B Cecatto, M.D., Ph.D.

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at Post-Graduate Program of Biophotonics Applied at Health Sciences

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: March 8, 2023
• Study Start: March 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 8, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)