Burning Mouth SyndromeNCT04203134
Burning Mouth Syndrome Mouth Guard Prospective Study
A study testing Mouthguard in people with Burning Mouth Syndrome and Burning Mouth, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Burning Mouth Syndrome, Burning Mouth
- What is being tested?
- Mouthguard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 18 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New patients diagnosed with BMS seen in the oral medicine clinic for the study period.
Who cannot join
- Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Dentistry
Gainesville, Florida, 32610
About this study
Official title: Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)
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.
Read the 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.
- Conditions
- Burning Mouth Syndrome, Burning Mouth
- Being tested
- Mouthguard
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Baseline through 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start15 Jan 2020
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin Belknap, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203134
- Sponsor's protocol ID
- IRB201902692
- Other IDs
- OCR29702
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)
- ClinicalTrials.gov ID
- NCT04203134
- Acronym / sponsor ID
- IRB201902692
- Conditions
- Burning Mouth Syndrome, Burning Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: MouthguardPatients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS. |
| Control Group | No intervention | –Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New patients diagnosed with BMS seen in the oral medicine clinic for the study period.
Key exclusion criteria (1 listed)
- Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MouthguardThe 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. | Device | Treatment Group |
Primary outcome
Effectiveness in pain control
Time frame: 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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austin Belknap principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthguard in people with Burning Mouth Syndrome and Burning Mouth, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness in pain control (time frame: Baseline through 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.