NCT07016555

Brief Summary

This research study aims to evaluate how an oral cooling spray, currently a commercial dietary supplement, impacts symptoms associated with burning mouth syndrome (BMS). This study will examine symptoms, frequency, and severity, along with other related side effects of BMS on food intake, enjoyment, and quality of life.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 4, 2025

Last Update Submit

June 4, 2025

Conditions

Burning Mouth Syndrome

Keywords

Symptom managementburning mouth syndromeoral spray

Outcome Measures

Primary Outcomes (1)

  • Improved symptoms

    Frequency, severity, and duration of oral burn between regular treatment decreases after 2 weeks of using the oral spray

    2 weeks

Study Arms (1)

Oral spray

EXPERIMENTAL

Oral spray

Dietary Supplement: Oral cooling spray

Interventions

Oral cooling sprayDIETARY_SUPPLEMENT

Use oral spray 3 times per day for 2 weeks

Oral spray

Eligibility Criteria

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

You may qualify if:

  • Have buring mouth syndrome or experience oral burn
  • Live in the United States
  • At least 18 years old
  • Having been diagnosed or suspected diagnosis of burning mouth syndrome or suffer from chronic oral burn without any identifiable causative lesion
  • No tongue or cheek piercings
  • No history of cancer
  • No recent or scheduled dental treatment
  • No history of gum disease
  • No aversions to mint or hop extracts

You may not qualify if:

  • Have recently undergone dental treatment in the last three months or have plans to undergo dental treatment (e.g., fillings, crowns, root canals, extractions, or other dental procedures) in the coming month.
  • Have started any new treatments for BMS in the last 3 months or have plans to start new treatments in the coming month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Amherst

Amherst, Massachusetts, 01002, United States

RECRUITING

MeSH Terms

Conditions

Burning Mouth Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Central Study Contacts

Alissa Nolden, PhD

CONTACT

413-577-0113anolden@umass.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 11, 2025

Study Start

June 11, 2025

Primary Completion

August 31, 2025

Study Completion

December 15, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)