Burning Mouth Syndrome Mouth Guard Prospective Study

NCT ID: NCT04203134

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-06-18

Brief Summary

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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

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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.

Conditions

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Burning Mouth Syndrome Burning Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

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

Group Type EXPERIMENTAL

Mouthguard

Intervention Type 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.

Control Group

Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• New patients diagnosed with BMS seen in the oral medicine clinic for the study period.

Exclusion Criteria

• Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Austin Belknap

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida College of Dentistry

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OCR29702

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201902692

Identifier Type: -

Identifier Source: org_study_id

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