Theravex® for Burning Mouth Syndrome

Mineral-ionic Magnesium/Calcium Oral Rinse (THERAVEX® Total Oral Care Plus) in Primary Burning Mouth Syndrome: a Double-blind Randomized Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Primary Burning Mouth Syndrome (BMS)
• Intervention / Treatment: Device: THERAVEX® Total Oral Care Plus

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Maxillofacial surgery department, Alexandria university hospital, Alexandria university, Alexandria, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THERAVEX® Total Oral Care Plus (Mineral-Ionic Oral Rinse)	Device: 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.
Placebo Comparator: Placebo Oral Rinse	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Burning Pain Intensity (Numeric Rating Scale, NRS)	Change in intraoral burning pain intensity from baseline to Week 8, measured using an 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). Participants reported their average daily pain over the preceding week at each assessment time point.	8 weeks

Collaborators and Investigators

• Sponsor: Biointelligent Technology Systems SL
• Collaborators: Alexandria University; Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2024
• Primary Completion (Actual): October 6, 2024
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Soh-med-24-10-PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes. Individual Participant Data (IPD) that underlie the results reported in this study, after de-identification, will be made available upon reasonable request to the corresponding author, subject to institutional review and data-sharing agreements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No