XerostomiaPhase 2NCT05760092
The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19.A Randomized Controlled Trial.
A Phase 2 study testing Institutional standard treatment for xerostomia and Long Covid and Photobiomodulation Therapy in people with Xerostomia and COVID-19, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Xerostomia, COVID-19, Long COVID
- What is being tested?
- Institutional standard treatment for xerostomia and Long Covid and Photobiomodulation Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2023to 8 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
São Paulo
About this study
Official title: The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19. A Randomized Controlled Trial.
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.
Read the detailed description
Coronavirus (COVID-19) is a newly emerging zoonotic agent that emerged in December 2019 in China (2019-nCoV) and which results in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV -2) The scientific literature has made progress in the characterization of the new coronavirus and works extensively on therapies and vaccines against the virus. However, it is now known that SARS-CoV-2 is more than just an acute respiratory syndrome. Long-term COVID-19, or Post-Covid Syndrome or Long-term COVID-19, is a post-viral syndrome that was first reported online in groups of COVID-19 survivors discussing their symptoms after the acute infection has resolved. It begins to gain recognition in the scientific and medical communities. Although a universally accepted definition does not yet exist, reviews have identified that 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 xerostomia. Xerostomia is defined as a subjective sensation of dry mouth described by patients and which is commonly related to hyposalivation (decreased salivary flow rate). The pathophysiology and clinical evolution of xerostomia in COVID-19 still lacks studies, but there are reports of 2 to 30% of patients presenting the complaint of dry mouth sensation even after the resolution of acute COVID. Regular physical therapy, cognitive behavioral therapy have been used and encouraged in the follow-up of patients with post- COVID, demonstrating that even today these practices seem to be more promising than pharmacological treatment. In parallel, studies demonstrate that 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 these patients. PBM refers to a series of therapies in which non-ionizing light beams, including lasers, LEDs and broadband light in the visible and infrared spectra, are used to interact with biological tissues for different purposes. In this sense, this study aims to investigate the clinical effectiveness of the use of a Photobiomodulation protocol in the treatment xerostomia related to Long-Covid. This will be a single-center, randomized, controlled, blind 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). An analysis will be carried out of all medical records of patients who remained hospitalized with COVID-19 at Lydia Storópoli Universitary Hospital during the year 2022 and who were discharged from the inpatient treatment from January to December 2022, for a survey of telephone contact and epidemiological data collection by medical records. All those patients who answer the questions referring to one or more symptoms related to the oral or nasal cavity, which have arisen after the onset of acute COVID infection, will be invited to participate in the study by making a first face-to-face evaluation at the University to confirm the diagnostic criteria of xerostomia, the diagnosis of Long COVID and evaluation of inclusion criteria in the study (adults with COVID-19 with complaints of xerostomia diagnosed more than 4 weeks after the acute infection and persisting for at least 02 months). Pre- and post-treatment evaluations are composed by the Brazilian Version of the SF 36 Quality of Life Scale, salivary sialometry and salivary pH, Oral Health Impact Profile (OHIP-14), Abbreviated Xerostomia Inventory (SXI), Brazilian version of the Functional Independence Measure (FIM), Post -Covid-19 Functional Status Scale and WHO Disability Assessment Scale (WHODAS 2.0) All patients included 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. The results will be sent for statistical analysis.
- Conditions
- Xerostomia, COVID-19, Long COVID, Persistent COVID-19
- Being tested
- Institutional standard treatment for xerostomia and Long Covid, Photobiomodulation Therapy, Placebo Photobiomodulation Therapy
- Keywords
- Xerostomia, Dry Mouth, COVID-19, Long Covid, Photobiomodulation
- Medical subject headings
- Xerostomia, COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Institutional standard treatment for xerostomia and Long CovidCombination 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 TherapyRadiation
Also called PBM 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.
Placebo Photobiomodulation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Therapy | Experimental | Institutional standard treatment for xerostomia and COVID Longa + PBM therapy Receives: 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 Receives: Combination Product: Institutional standard treatment for xerostomia and Long Covid; Radiation: Placebo Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: pre-treatment and post-treatment (after 04 weeks of treatment)
Xerostomia Inventory XI
A multi-item approach to measuring and quantify dry mouth.
Measured: 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
Measured: 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.
Measured: 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)
Measured: pre-treatment and post-treatment (after 04 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Feb 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Boltes Cecatto, University of Nove de Julho
- Investigators
- Rebeca B Cecatto, M.D., Ph.D., Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760092
- Sponsor's protocol ID
- Covidlongasusy
- Status last verified
- Mar 2024
- First submitted
- 20 Sep 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34919045Verma 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.
PubMed 35059791
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05760092
- Acronym / sponsor ID
- Covidlongasusy
- Conditions
- Xerostomia, COVID-19, Long COVID, Persistent COVID-19
- Keywords
- Xerostomia, Dry Mouth, COVID-19, Long Covid, Photobiomodulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coronavirus (COVID-19) is a newly emerging zoonotic agent that emerged in December 2019 in China (2019-nCoV) and which results in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV -2) The scientific literature has made progress in the characterization of the new coronavirus and works extensively on therapies and vaccines against the virus. However, it is now known that SARS-CoV-2 is more than just an acute respiratory syndrome. Long-term COVID-19, or Post-Covid Syndrome or Long-term COVID-19, is a post-viral syndrome that was first reported online in groups of COVID-19 survivors discussing their symptoms after the acute infection has resolved. It begins to gain recognition in the scientific and medical communities. Although a universally accepted definition does not yet exist, reviews have identified that 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 xerostomia. Xerostomia is defined as a subjective sensation of dry mouth described by patients and which is commonly related to hyposalivation (decreased salivary flow rate). The pathophysiology and clinical evolution of xerostomia in COVID-19 still lacks studies, but there are reports of 2 to 30% of patients presenting the complaint of dry mouth sensation even after the resolution of acute COVID. Regular physical therapy, cognitive behavioral therapy have been used and encouraged in the follow-up of patients with post- COVID, demonstrating that even today these practices seem to be more promising than pharmacological treatment. In parallel, studies demonstrate that 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 these patients. PBM refers to a series of therapies in which non-ionizing light beams, including lasers, LEDs and broadband light in the visible and infrared spectra, are used to interact with biological tissues for different purposes. In this sense, this study aims to investigate the clinical effectiveness of the use of a Photobiomodulation protocol in the treatment xerostomia related to Long-Covid. This will be a single-center, randomized, controlled, blind 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). An analysis will be carried out of all medical records of patients who remained hospitalized with COVID-19 at Lydia Storópoli Universitary Hospital during the year 2022 and who were discharged from the inpatient treatment from January to December 2022, for a survey of telephone contact and epidemiological data collection by medical records. All those patients who answer the questions referring to one or more symptoms related to the oral or nasal cavity, which have arisen after the onset of acute COVID infection, will be invited to participate in the study by making a first face-to-face evaluation at the University to confirm the diagnostic criteria of xerostomia, the diagnosis of Long COVID and evaluation of inclusion criteria in the study (adults with COVID-19 with complaints of xerostomia diagnosed more than 4 weeks after the acute infection and persisting for at least 02 months). Pre- and post-treatment evaluations are composed by the Brazilian Version of the SF 36 Quality of Life Scale, salivary sialometry and salivary pH, Oral Health Impact Profile (OHIP-14), Abbreviated Xerostomia Inventory (SXI), Brazilian version of the Functional Independence Measure (FIM), Post -Covid-19 Functional Status Scale and WHO Disability Assessment Scale (WHODAS 2.0) All patients included 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. The results will be sent for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Therapy | Experimental | Combination Product: Institutional standard treatment for xerostomia and Long Covid, Radiation: Photobiomodulation TherapyInstitutional standard treatment for xerostomia and COVID Longa + PBM therapy |
| Placebo Photobiomodulation | Placebo comparator | Combination Product: Institutional standard treatment for xerostomia and Long Covid, Radiation: Placebo Photobiomodulation TherapyInstitutional standard treatment for xerostomia and COVID Longa + PBM placebo therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (25 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ) + | Combination product | Photobiomodulation Therapy, Placebo Photobiomodulation |
| Photobiomodulation TherapyAlso: PBM therapyApplication 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. | Radiation | Photobiomodulation Therapy |
| Placebo Photobiomodulation TherapyAll 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. | Radiation | Placebo Photobiomodulation |
Primary outcome
Brazilian version of the SF 36 Quality of Life Scale
Time frame: pre-treatment and post-treatment moment (after 04 weeks of treatment)
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.
Nutritional assessment
Time frame: pre-treatment and post-treatment (after 04 weeks of treatment)
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.
Salivary ph, Stimulated salivary flow and unstimulated salivary flow
Time frame: pre-treatment and post-treatment (after 04 weeks of treatment)
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.
Oral Health Impact Profile (OHIP-14)
Time frame: pre-treatment and post-treatment (after 04 weeks of treatment)
Assessment of Oral Health-related Quality of Life, by OHIP-14 , translated and validated for Brazilian population
Xerostomia Inventory XI
Time frame: pre-treatment and post-treatment (after 04 weeks of treatment)
A multi-item approach to measuring and quantify dry mouth.
Functional Independence Measure (FIM)
Time frame: pre-treatment and post-treatment (after 04 weeks of treatment)
A translated and validated for the Brazilian population of general assessment of functional independence
Post-Covid-19 Functional Status Scale
Time frame: pre-treatment and post-treatment (after 04 weeks of treatment)
A tool to measure the full spectrum of functional outcomes following COVID-19.
The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time frame: pre-treatment and post-treatment (after 04 weeks of treatment)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 34919045Chowdhury 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.
- Results publication: PubMed 35059791Verma 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.
- Individual participant dataSharing planned: No
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Sjögren's Syndrome, Small Fiber Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebeca B Cecatto, M.D., Ph.D. principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Institutional standard treatment for xerostomia and Long Covid and Photobiomodulation Therapy in people with Xerostomia and COVID-19, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brazilian version of the SF 36 Quality of Life Scale (time frame: pre-treatment and post-treatment moment (after 04 weeks of treatment)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760092, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.