Burning Mouth Syndrome Mouth Guard Prospective Study

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.

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Key information

Conditions

Burning Mouth Syndrome Burning Mouth Mouth Diseases Stomatognathic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mouthguard

Device

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.

Primary outcomes

Effectiveness in pain control

Time frame: Baseline through 6 month

patient reported pain level using self reported word descriptor scale. Range from 0 - 5, with 0 as "no pain" and 5 as "excruciating pain"

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 18, 2019
Registry last updated: Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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