Primary Burning Mouth Syndrome (BMS)
Conditions
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.
Interventions
DEVICETHERAVEX® 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.
Sponsors
Biointelligent Technology Systems SL
Sohag University
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple : Participant, Care Provider, Investigator, Outcomes Assessor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Burning Pain Intensity (Numeric Rating Scale, NRS) | 8 weeks | 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. |
Countries
Egypt
Outcome results
None listed