Primary Burning Mouth Syndrome (BMS)NCT07564843
Theravex® for Burning Mouth Syndrome
A study testing THERAVEX® Total Oral Care Plus in people with Primary Burning Mouth Syndrome (BMS), run by Biointelligent Technology Systems SL at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Burning Mouth Syndrome (BMS)
- What is being tested?
- THERAVEX® Total Oral Care Plus
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Maxillofacial surgery department, Alexandria university hospital, Alexandria university, Alexandria, Egypt
Alexandria
About this study
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
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)
- Being tested
- THERAVEX® Total Oral Care Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAVEX® Total Oral Care PlusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| THERAVEX® Total Oral Care Plus (Mineral-Ionic Oral Rinse) | Active comparator | Not described Receives: Device: THERAVEX® Total Oral Care Plus |
| Placebo Oral Rinse | Placebo comparator | Not described Receives: Device: THERAVEX® Total Oral Care Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start6 Oct 2024
- Primary completion6 Oct 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Burning Mouth Syndrome (BMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biointelligent Technology Systems SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sohag University, Alexandria University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564843
- Sponsor's protocol ID
- Soh-med-24-10-PD
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Carrio N, Garawani BE, Alahmad A, Atari F, Ferres-Amat E, Bassil J, Amer IA, Badrah M, Shabaan AA, Kassem I. Efficacy of magnesium-calcium ionic oral rinse for primary burning mouth syndrome: a randomized, double-blind, placebo-controlled trial. BMC Oral Health. 2026 Jul 20;26(1):1314. doi: 10.1186/s12903-026-09296-1.
PubMed 42472793
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07564843
- Acronym / sponsor ID
- Soh-med-24-10-PD
- Conditions
- Primary Burning Mouth Syndrome (BMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Biointelligent Technology Systems SLIndustry (pharma, biotech, devices)
- Collaborators
- Sohag University, Alexandria University
- Study start
- 6 Oct 2024 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERAVEX® Total Oral Care PlusParticipants 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. | Device | Placebo Oral Rinse, THERAVEX® Total Oral Care Plus (Mineral-Ionic Oral Rinse) |
Primary outcome
Change in Burning Pain Intensity (Numeric Rating Scale, NRS)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 42472793Carrio N, Garawani BE, Alahmad A, Atari F, Ferres-Amat E, Bassil J, Amer IA, Badrah M, Shabaan AA, Kassem I. Efficacy of magnesium-calcium ionic oral rinse for primary burning mouth syndrome: a randomized, double-blind, placebo-controlled trial. BMC Oral Health. 2026 Jul 20;26(1):1314. doi: 10.1186/s12903-026-09296-1.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THERAVEX® Total Oral Care Plus in people with Primary Burning Mouth Syndrome (BMS), run by Biointelligent Technology Systems SL at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Burning Pain Intensity (Numeric Rating Scale, NRS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07564843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.