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Recruiting EARLY_Phase 1 NCT07016555

NCT07016555 Burning Mouth Syndrome: Symptoms and Management

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Clinical Trial Summary
NCT ID NCT07016555
Status Recruiting
Phase EARLY_Phase 1
Sponsor University of Massachusetts, Amherst
Condition Burning Mouth Syndrome
Study Type INTERVENTIONAL
Enrollment 50 participants
Start Date 2025-06-11
Primary Completion 2025-08-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Oral cooling spray

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 50 participants in total. It began in 2025-06-11 with a primary completion date of 2025-08-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Alissa Nolden, PhD

✉ anolden@umass.edu

📞 413-577-0113

Frequently Asked Questions

Who can join the NCT07016555 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Burning Mouth Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07016555 trial and what does that mean for participants?

Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.

Is NCT07016555 currently recruiting?

Yes, NCT07016555 is actively recruiting participants. Contact the research team at anolden@umass.edu for enrollment information.

Where is the NCT07016555 trial being conducted?

This trial is being conducted at Amherst, United States.

Who is sponsoring the NCT07016555 clinical trial?

NCT07016555 is sponsored by University of Massachusetts, Amherst. The trial plans to enroll 50 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology