Diode Laser 940 nm in Management of Loss of Taste Sensation

Not Applicable

Completed

• Conditions: SARS-CoV Infection
• Interventions: Device: a 940-nm diode laser

• Registration Number: NCT04821999
• Lead Sponsor: Fayoum University

Brief 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 %

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 Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-03-30
• Study Start: 2021-04-10
• Primary Completion: 2021-09-20
• Study Completion: 2021-10-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	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.

Primary Outcome Measures

Name	Time	Method
taste sensation survey	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).

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Fayoum, Egypt