Diode Laser 940 nm in Management of Loss of Taste Sensation

SARS-CoV Infection Clinical Trial

Official title:

Diode Laser 940 nm in Management of Loss of Taste Sensation in Patients With Post SARS-CoV 2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821999
• Other study ID #: Laser SARS-CoV2
• Status: Completed
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The global pandemic has recently emerged by transmission of SARS-CoV2 virus. The virus has had a massive impact on health, wealth and social aspects worldwide. Since the identification of this virus in Wuhan, China, millions of cases has been diagnosed worldwide with mortality rates ranging from 3% to 12 %

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ageusia
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Device:
• a 940-nm diode laser
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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Halboub E, Al-Maweri SA, Alanazi RH, Qaid NM, Abdulrab S. Orofacial manifestations of COVID-19: a brief review of the published literature. Braz Oral Res. 2020 Oct 30;34:e124. doi: 10.1590/1807-3107bor-2020.vol34.0124. eCollection 2020. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	taste sensation survey	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