- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821999
Diode Laser 940 nm in Management of Loss of Taste Sensation
Diode Laser 940 nm in Management of Loss of Taste Sensation in Patients With Post SARS-CoV 2 Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
'Long COVID' is emerging as a phenomenon where patients have long-term unresolved symptoms (8,9). These could be prolonged symptoms of SARS-CoV2 or a posteSARS-CoV2 syndrome for which dysfunction of smell and taste sensation has been proposed.
The proposal presents the diode laser 940 as possible treatment for the loss of taste sensation in patients with long SARS-CoV2. The effect of low levels of laser energy was first discovered by Dr Endre Mester in 1967.5 Since then it has been used for various applications in the field of medicine and dentistry and is broadly termed 'low level laser therapy'(LLLT) or 'biostimulation' or 'phototherapy'. It is defined as a 'non-thermal' laser light application using photons (light energy) from the visible and infrared spectrum for tissue healing and pain reduction (North American Association of Laser Therapy-NAALT). Several in vitro studies have demonstrated that the effects of laser light on wound healing are much greater than obtained with light from other sources, such as light-emitting diodes (LEDs).(10-13)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Fayoum, Egypt, 63514
- Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A diagnosis of SARS-CoV2 with PCR. Age range from 18-60 years old Loss of taste sensation
Exclusion Criteria:
Pregnancy or contraceptive pills Lactation Any auto-immune disease that could affect the oral mucosa On any neoplastic therapy. Uncontrolled diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group I
a 940-nm diode laser (EPIC™, BIOLASE, www.biolase.com)
with an adjustable pain therapy handpiece capable of creating diffuse laser energy patterns ranging from 15 mm to 30 mm in size.
|
a 940-nm diode laser (EPIC™, BIOLASE, www.biolase.com)
with an adjustable pain therapy handpiece capable of creating diffuse laser energy patterns ranging from 15 mm to 30 mm in size.
|
No Intervention: group II
No treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
taste sensation survey
Time Frame: 6 weeks
|
The participated patients will be assessed using the taste questionnaire using a category scale for rating taste intensity and a forced choice for identifying the taste quality of each sample ( salty, sweet and bitter).
|
6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Neurologic Manifestations
- Sensation Disorders
- Taste Disorders
- Severe Acute Respiratory Syndrome
- Infections
- Ageusia
Other Study ID Numbers
- Laser SARS-CoV2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on SARS-CoV Infection
-
St. Olavs HospitalThe Research Council of Norway; Helse Nord-Trøndelag HF; Alesund Hospital; Namsos... and other collaboratorsCompletedSARS-CoV-2 Acute Respiratory Disease | SARS-CoV-2 Sepsis | SARS CoV 2 InfectionNorway
-
Boston UniversityNational Institute of Allergy and Infectious Diseases (NIAID); Burnet Institute and other collaboratorsRecruitingSARS CoV 2 Infection | SARS CoV 2 VaccinationUnited States, Malawi
-
Chulalongkorn UniversityRamathibodi Hospital; Ministry of Health, Thailand; The Government Pharmaceutical... and other collaboratorsCompletedSARS-CoV-2 Acute Respiratory Disease | SARS CoV 2 InfectionThailand
-
Sophia Koo, M.D.Massachusetts General Hospital; GlaxoSmithKline; Dana-Farber Cancer InstituteActive, not recruitingSARS CoV 2 InfectionUnited States
-
Banaras Hindu UniversityCompleted
-
Firalis SAIstanbul UniversityRecruiting
-
The Board of MedicineApollo Neuroscience, Inc.RecruitingPost-acute Sequelae of SARS-COV-2 InfectionUnited States
-
Imam Abdulrahman Bin Faisal UniversityDammam Medical Complex; Institute for Research and medical consultations (IRMC)UnknownHospitalized Patients | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV 2 Infection) | Laboratory-confirmed SARS-CoV 2 InfectionSaudi Arabia
-
BioNTech SECompletedCOVID-19 | SARS-CoV2 Infection | SARS-CoV-2 Acute Respiratory Disease | SARS (Disease)United States, Germany, Turkey, South Africa
-
Rutgers, The State University of New JerseyNational Institute of Dental and Craniofacial Research (NIDCR)Completed
Clinical Trials on a 940-nm diode laser
-
October 6 UniversityCompleted
-
Hams Hamed AbdelrahmanRecruitingDental Implant | Soft Tissue Healing | Bone HealingEgypt
-
Trakya UniversityCompletedFrenulum; Hypertrophy
-
Yuzuncu Yıl UniversityCompletedPostoperative Pain | Wound Heal | Soft Tissue BleedingTurkey
-
Yuzuncu Yıl UniversityCompletedAggressive Periodontitis
-
Academy of Laser Dentistry - Gulf Laser ChapterDamascus UniversityCompletedHyperpigmentation; Melanin | Laser-Induced HyperpigmentationQatar
-
Instituto Vascular BHCompleted
-
Alexandria UniversityCompletedDentin HypersensitivityEgypt
-
National Taiwan University HospitalBRIDGECON CO,.LTD.RecruitingLaser | PeriorbitalTaiwan