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Theravex® for Burning Mouth Syndrome
Sponsor: Biointelligent Technology Systems SL
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.
Official title: Mineral-ionic Magnesium/Calcium Oral Rinse (THERAVEX® Total Oral Care Plus) in Primary Burning Mouth Syndrome: a Double-blind Randomized Placebo-controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2024-10-06
Completion Date
2025-09-01
Last Updated
2026-05-04
Healthy Volunteers
Yes
Conditions
Interventions
THERAVEX® Total Oral Care Plus
Participants assigned to the active arm received a mineral-ionic oral rinse containing magnesium chloride and calcium chloride (THERAVEX® Total Oral Care Plus). They were instructed to rinse with 10 mL of the solution for 60 seconds, three times daily, for a total duration of 8 weeks. Participants were advised to refrain from eating or drinking for at least 30 minutes after each use to ensure adequate mucosal exposure.
Locations (1)
Maxillofacial surgery department, Alexandria university hospital, Alexandria university, Alexandria, Egypt
Alexandria, Egypt