Botulinum Toxin in Burning Mouth Syndrome
- Conditions
- Burning Mouth Syndrome
- Interventions
- Drug: Botulinum Neurotoxin Type AOther: Normal saline
- Registration Number
- NCT02964728
- Lead Sponsor
- Presidio Ospedaliero Garibaldi-Centro
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- burning mouth syndrome
- any other mouth disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Botulinum toxin type A Botulinum Neurotoxin Type A Botulinum neurotoxin injections Placebo Normal saline Normal saline solution injections
- Primary Outcome Measures
Name Time Method 0-100 mm Visual Analog Scale (VAS) improvement 1 month
- Secondary Outcome Measures
Name Time Method