An interventional study of Mouthguard in Burning Mouth Syndrome and Burning Mouth, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
44 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
This study's enrollment of 8 is below the median of 42 across 35 interventional studies indexed under Burning Mouth Syndrome.
Browse Burning Mouth Syndrome studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion criteria includes:
Inclusion Criteria:
Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.
Device: Mouthguard
Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a 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.
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"
Time frame: Baseline through 6 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University of Florida