Theravex® for Burning Mouth Syndrome (NCT07564843) | Clinical Trial Compass
CompletedNot Applicable
Theravex® for Burning Mouth Syndrome
Egypt116 participantsStarted 2024-10-06
Plain-language summary
In this randomized, double-blind, placebo-controlled trial, 116 adults with primary BMS were assigned (1:1) to receive THERAVEX® Total Oral Care Plus or placebo for 8 weeks. Participants rinsed 10 mL for 60 seconds three times daily. The primary outcome was change in burning pain intensity (Numeric Rating Scale, NRS). Secondary outcomes included responder rate (≥2-point NRS reduction), Oral Health Impact Profile-14 (OHIP-14), Xerostomia Inventory, Patient Global Impression of Change (PGIC), and safety assessments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged ≥18 years. Diagnosis of primary Burning Mouth Syndrome (BMS) according to International Classification of Orofacial Pain (ICOP) and ICHD-3 criteria.
Daily intraoral burning or dysaesthetic sensation persisting for ≥3 months and occurring ≥2 hours per day.
Clinically normal oral mucosa without visible lesions. Absence of identifiable local or systemic causes of oral burning following standard diagnostic workup.
Ability and willingness to comply with study procedures and provide written informed consent.
Exclusion Criteria:
Presence of secondary causes of oral burning (e.g., oral candidiasis, nutritional deficiencies, uncontrolled diabetes mellitus, thyroid disorders).
Autoimmune diseases affecting the oral cavity (e.g., Sjögren syndrome). Active oral mucosal pathology or lesions. Pregnancy or breastfeeding. Known hypersensitivity to any component of the study product. Use of topical clonazepam, capsaicin, systemic neuromodulators, or other treatments for BMS within 14 days prior to enrollment.
Severe psychiatric disorders or conditions that could interfere with study participation or outcome assessment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this Theravex trial for Burning Mouth Syndrome is already completed, has the results data been published yet, and is there any way to review what the study found about changes in burning pain intensity before we decide on a treatment path?
2Burning Mouth Syndrome can be really hard to manage — given that this trial used a numeric pain rating scale as its main measure, what level of pain reduction would actually be meaningful for my daily life, and does what's known about Theravex so far suggest it could reach that threshold?
3Since the trial phase is listed as 'NA,' what does that tell you about how much safety and effectiveness data exists for Theravex compared to other treatments you might already recommend for primary Burning Mouth Syndrome?
4Are there any standard or off-label treatments for primary Burning Mouth Syndrome that have stronger evidence behind them right now, and should we consider those while we wait for the full results of this completed trial to become available?
5Would it be worth reaching out to the researchers who ran this Theravex trial to find out more about their findings, or are there any follow-up studies in the works that I might be eligible to discuss with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Burning Pain Intensity (Numeric Rating Scale, NRS)