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Trial record 2 of 20 for:    "Burning Mouth Syndrome"

Botulinum Toxin in Burning Mouth Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02964728
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : December 7, 2016
Carlo Besta Neurological Institute
University of Catania
University of Padova
Information provided by (Responsible Party):
Domenico Antonio Restivo, 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.

Condition or disease Intervention/treatment Phase
Burning Mouth Syndrome Drug: Botulinum Neurotoxin Type A Other: Normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Botulinum Toxin in Burning Mouth Syndrome
Study Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Botulinum toxin type A
Botulinum neurotoxin injections
Drug: Botulinum Neurotoxin Type A
topical injection

Placebo Comparator: Placebo
Normal saline solution injections
Other: Normal saline
topical injection

Primary Outcome Measures :
  1. 0-100 mm Visual Analog Scale (VAS) improvement [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • burning mouth syndrome

Exclusion Criteria:

  • any other mouth disorder

Publications of Results:
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Responsible Party: Domenico Antonio Restivo, MD, Presidio Ospedaliero Garibaldi-Centro Identifier: NCT02964728     History of Changes
Other Study ID Numbers: BMS-1
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Burning Mouth Syndrome
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents