Recruiting
Early Phase 1

Oral Cooling Spray

Sponsor:

University of Massachusetts, Amherst

Code:

NCT07016555

Conditions

Burning Mouth Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral cooling spray

Study Details

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.

Conditions

Burning Mouth Syndrome

Study ID

NCT07016555

Start date

Jun 11, 2025

Status verified date

Jun, 2025

Completion date

Dec 15, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Oral spray

Oral spray

Interventions

Oral cooling spray

Use oral spray 3 times per day for 2 weeks

Primary outcome measure

  • Improved symptoms [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Alissa Nolden, PhD

413-577-0113anolden@umass.edu

Locations

UMass Amherst

Recruiting

Amherst, Massachusetts, United States, 01002

More Information

Sponsor

University of Massachusetts, Amherst

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • Symptom management
  • burning mouth syndrome
  • oral spray

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Amherst on 2025-06-11.