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NCT04203134 Clinical Trial

Burning Mouth Syndrome Mouth Guard Prospective Study

Burning Mouth Syndrome Clinical Trial

Official title:
Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04203134
Other study ID # IRB201902692
Secondary ID OCR29702
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2020
Est. completion date June 18, 2021

Study information
Verified date January 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will seek to test the effectiveness of a nonpharmacologic therapy for burning mouth syndrome (BMS). This nonpharmacologic therapy approach will be the fabrication a protective acrylic mouthguard for the maxillary arch and palate.

Description:

The study involves a nonpharmacologic and non-invasive treatment method for BMS which will be administered randomly (flipping a coin) to half of the study subjects, (case group) in addition to normal condition treatment protocol for BMS.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 18, 2021
Est. primary completion date June 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: • New patients diagnosed with BMS seen in the oral medicine clinic for the study period. Exclusion criteria includes: • Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis Inclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mouthguard
The mouthguard is a thin clear acrylic protector fabricated from an impression of a patient's upper teeth and palate. The acrylic protector will be trimmed and will fit onto the patient's upper teeth and palate for use during the day, except when eating to minimize trauma to the tongue that exacerbates burning tongue pain.

Locations
Country Name City State
United States University of Florida College of Dentistry Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness in pain control patient reported pain level using self reported word descriptor scale. Range from 0 - 5, with 0 as "no pain" and 5 as "excruciating pain" Baseline through 6 month
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