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Botulinum Toxin in Burning Mouth Syndrome

Botulinum Toxin in Burning Mouth Syndrome

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02964728
Enrollment
6
Registered
2016-11-16
Start date
2015-11-30
Completion date
2016-05-31
Last updated
2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome

Brief summary

The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4 patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds of the tongue and the lower lip for at least 6 months, refractory to common pharmacological treatments. Pain severity will be measured by the visual analog scale (VAS) indicating average week pain before injection. Each patient will be injected with a total dose of 16 units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and 4 units into each antero-lateral side of the tongue. In order to determine if a placebo effect may be involved, we will inject 2 additional patients with saline solution using the same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at 4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated after 4 weeks with incobotulinumA with the same dose reported above.

Interventions

topical injection

OTHERNormal saline

topical injection

Sponsors

Carlo Besta Neurological Institute
CollaboratorOTHER
University of Catania
CollaboratorOTHER
University of Padova
CollaboratorOTHER
Presidio Ospedaliero Garibaldi-Centro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* burning mouth syndrome

Exclusion criteria

* any other mouth disorder

Design outcomes

Primary

MeasureTime frame
0-100 mm Visual Analog Scale (VAS) improvement1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026