Burning Mouth Syndrome Mouth Guard Prospective Study

Not Applicable

Completed

• Conditions: Burning Mouth; Burning Mouth Syndrome
• Interventions: Device: Mouthguard

• Registration Number: NCT04203134
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Study Start: 2020-01-15
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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:

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Mouthguard	Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.

Primary Outcome Measures

Name	Time	Method
Effectiveness in pain control	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"

Trial Locations

Locations (1)

University of Florida College of Dentistry; 🇺🇸 Gainesville, Florida, United States