Burning Mouth Syndrome Mouth Guard Prospective Study

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.