Back to resultsBurning Mouth Syndrome Mouth Guard Prospective Study
Primary Purpose
Burning Mouth Syndrome, Burning Mouth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mouthguard
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome
Eligibility 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:
Sites / Locations
- University of Florida College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Control Group
Arm Description
Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.
Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard.
Outcomes
Primary Outcome Measures
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"
Secondary Outcome Measures
Full Information
NCT ID
NCT04203134
First Posted
December 16, 2019
Last Updated
January 3, 2022
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT04203134
Brief Title
Burning Mouth Syndrome Mouth Guard Prospective Study
Official Title
Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome, Burning Mouth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard.
Intervention Type
Device
Intervention Name(s)
Mouthguard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness in pain control
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Austin Belknap
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida College of Dentistry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Burning Mouth Syndrome Mouth Guard Prospective Study
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