Burning Mouth, Burning Mouth Syndrome
Conditions
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.
Interventions
DEVICEMouthguard
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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed