Theravex® for Burning Mouth Syndrome

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.

NCT Number	NCT07564843
Lead Sponsor	Biointelligent Technology Systems SL Collaborators: Sohag University, Alexandria University
Conditions	Primary Burning Mouth Syndrome (BMS)
Enrollment	116 participants
Start Date	2024-10-06
Primary Completion	2024-10-06 (estimated)
Study Completion	2025-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-04