Cannabis Sativa oil for the treatment of burning mouth syndrome
Not Applicable
Completed
- Conditions
- Oral HealthBurning mouth syndrome
- Registration Number
- ISRCTN97009661
- Lead Sponsor
- niversity of Turin
- Brief Summary
2020 results in https://pubmed.ncbi.nlm.nih.gov/33123730/ (added 02/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 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<br> 2. Reported adverse events due to the THC treatment assessed from patient notes at the end of the study<br> 3. Unexpected effects assessed from patient diary records collected at the end of the study<br>