Burning Mouth Syndrome Mouth Guard Prospective Study

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT04203134
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burning Mouth Syndrome; Burning Mouth	Device: Mouthguard	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)
• Actual Study Start Date: Jan 15, 2020
• Actual Primary Completion Date: Jun 18, 2021
• Actual Study Completion Date: Jun 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.	Device: 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.
No Intervention: Control Group Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard.

Outcome Measures

Primary Outcome Measures

1. 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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida College of Dentistry	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Austin Belknap, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT04203134
• Other Study ID Numbers: IRB201902692; OCR29702
• First Posted: Dec 18, 2019
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Burning Mouth Syndrome; Syndrome; Burns

Study Results

No Results Posted as of Jan 4, 2022