Diode Laser 940 nm in Management of Loss of Taste Sensation

NCT04821999 | Completed

• 1 other identifier: Laser SARS-CoV2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 %

Conditions

SARS-CoV Infection

Keywords

SARS-CoV; , loss of taste; , Diode laser

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

group I

EXPERIMENTAL

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.

Device: a 940-nm diode laser

group II

NO INTERVENTION

No treatment

Interventions

a 940-nm diode laser DEVICE

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.

group I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A diagnosis of SARS-CoV2 with PCR. Age range from 18-60 years old Loss of taste sensation

You may not qualify if:

• Pregnancy or contraceptive pills Lactation Any auto-immune disease that could affect the oral mucosa On any neoplastic therapy. Uncontrolled diabetes.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Faculty of Dentistry

Al Fayyum, 63514, Egypt

Location

Related 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.

  PMID: 33146320 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Ageusia

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor in oral & maxillofacial Surgery Department

Model Details: Patients with SARS-CoV2 infection confirmed with PCR with loss of taste sensation

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: March 30, 2021
• Study Start: April 10, 2021
• Primary Completion: September 20, 2021
• Study Completion: October 1, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)