Burning Mouth Syndrome Mouth Guard Prospective Study

N/ACompletedNCT04203134

University of Florida8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burning Mouth Syndrome Burning Mouth

Interventions

MouthguardDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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:

Locations (1)

University of Florida College of Dentistry

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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"

Time frame: Baseline through 6 month

Data from ClinicalTrials.gov

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