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| ID | Type | Description | Link |
|---|---|---|---|
| OCR29702 | Other Identifier | University of Florida |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS. |
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| Control Group | No Intervention | Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouthguard | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in pain control | patient reported pain level using self reported word descriptor scale. Range from 0 - 5, with 0 as "no pain" and 5 as "excruciating pain" | Baseline through 6 month |
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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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| Name | Affiliation | Role |
|---|---|---|
| Austin Belknap | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Dentistry | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D009064 | Mouth Protectors |
| ID | Term |
|---|---|
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
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| D000067393 |
| Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |