Theravex® for Burning Mouth Syndrome

NCT07564843 | Completed DMC

• 1 other identifier: Soh-med-24-10-PD
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Burning Mouth Syndrome (BMS)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

THERAVEX® Total Oral Care Plus (Mineral-Ionic Oral Rinse)

ACTIVE COMPARATOR

Device: THERAVEX® Total Oral Care Plus

Placebo Oral Rinse

PLACEBO COMPARATOR

Device: THERAVEX® Total Oral Care Plus

Interventions

THERAVEX® Total Oral Care Plus DEVICE

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 Oral Rinse; THERAVEX® Total Oral Care Plus (Mineral-Ionic Oral Rinse)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biointelligent Technology Systems SL: lead
• Sohag University: collaborator
• Alexandria University: collaborator

Study Sites (1)

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

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple : Participant, Care Provider, Investigator, Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: October 6, 2024
• Primary Completion: October 6, 2024
• Study Completion: September 1, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)