Burning mouth syndrome Oral Health Burning mouth syndrome
Conditions
Interventions
This is a prospective, open-label study, that involves giving a galenic preparation of therapeutic Cannabis sativa to a cohort of subjects with an oral burning sensation. Caucasian patients, attending
Sponsors
University of Turin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 2. Burning mouth syndrome diagnosis 3. No detectable oral mucosal lesions 4. Able to complete the present clinical trial
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to provide informed consent 2. Significant psychiatric or cognitive impairment 3. Other diagnoses that could explain the neuropathic pain 4. Diagnosis of Sjögren Syndrome on the basis of AECG criteria 5. Previous head and neck radiotherapy 6. Diagnosed lymphoma 7. Hepatitis C infection 8. Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous pain intensity measured using the visual analogue scale (VAS), present pain intensity (PPI) scale, McGill Pain Questionnaire, and Oral Health Impact Profiles Profile questionnaires (OHIP-14, OHIP-19 and OHIP-49) at baseline, 4, 12 and 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Levels of anxiety and depression measured using Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (GDS) at baseline, 4, 12 and 36 weeks 2. Reported adverse events due to the THC treatment assessed from patient notes at the end of the study 3. Unexpected effects assessed from patient diary records collected at the end of the study | — |
Countries
Italy
Outcome results
None listed