NCT04203134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

December 16, 2019

Last Update Submit

January 3, 2022

Conditions

Burning Mouth SyndromeBurning Mouth

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.

Device: Mouthguard

Control Group

NO INTERVENTION

Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard.

Interventions

MouthguardDEVICE

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.

Treatment Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New patients diagnosed with BMS seen in the oral medicine clinic for the study period.

You may not qualify if:

  • Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Mouth Protectors

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Preventive DentistryDentistryProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Austin Belknap

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 18, 2019

Study Start

January 15, 2020

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)