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Burning Mouth Syndrome Mouth Guard Prospective Study

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University of Florida

Status

Completed

Conditions

Burning Mouth Syndrome
Burning Mouth

Treatments

Device: Mouthguard

Study type

Interventional

Funder types

Other

Identifiers

NCT04203134
IRB201902692
OCR29702 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

8 participants in 2 patient groups

Treatment Group
Experimental group
Description:
Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.
Treatment:
Device: Mouthguard
Control Group
No Intervention group
Description:
Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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