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Diode Laser 940 nm in Management of Loss of Taste Sensation

Primary Purpose

SARS-CoV Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
a 940-nm diode laser
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring SARS-CoV, , loss of taste, , Diode laser

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group I

group II

Arm Description

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 treatment

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
November 3, 2021
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT04821999
Brief Title
Diode Laser 940 nm in Management of Loss of Taste Sensation
Official Title
Diode Laser 940 nm in Management of Loss of Taste Sensation in Patients With Post SARS-CoV 2 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection
Keywords
SARS-CoV, , loss of taste, , Diode laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with SARS-CoV2 infection confirmed with PCR with loss of taste sensation
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group I
Arm Type
Experimental
Arm Description
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.
Arm Title
group II
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Device
Intervention Name(s)
a 940-nm diode laser
Intervention Description
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 Measure Information:
Title
taste sensation survey
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry
City
Fayoum
ZIP/Postal Code
63514
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33146320
Citation
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.
Results Reference
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Diode Laser 940 nm in Management of Loss of Taste Sensation

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