Condition category
Oral Health
Date applied
09/04/2020
Date assigned
06/05/2020
Last edited
02/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The International Headache Society has defined the Burning Mouth Syndrome (BMS) as “an intraoral burning or dysaesthetic (abnormal sensation) sensation, recurring daily for more than 2 hours per day over more than 3 months”.

The reported pain is described as moderate to severe, quite comparable to toothache in intensity, with a distinctive burning sensation, it is often accompanied by taste alterations and a dry mouth. By definition, clinical investigations and clinical sensory inspection are normal.

BMS management aims to reduce symptoms and pains, but no therapy has yet been shown to be effective. Currently, treatment is based on avoiding possible causes of mouth irritation and psychological support.

Cannabis (Cannabis sativa, or hemp) and its constituents (in particular the cannabinoids) have been the focus of extensive research. The plant's behavioural and psychotropic properties are attributed to its content of this class of compounds, the cannabinoids, which are produced mainly in the leaves and flower buds of the plant. There are also non-psychoactive cannabinoids with several medicinal functions, such as cannabidiol (CBD), cannabichromene (CBC), and cannabigerol (CBG), and many others.

In Italy, use of Cannabis sativa for therapeutic purposes (CTP) was first authorized in 2006. Suggestions for its use include chronic pain, nausea and vomitus associated to chemotherapy, appetite stimulation, low blood pressure in glaucoma, and lessening of uncontrolled body and facial movements.

This trial aims to test if the use of a full cannabis plant extract diluted in oil could be useful in reducing reported mouth pain.

Who can participate?
Adult patients with burning mouth syndrome

What does the study involve?
Patients suffering from atypical oral burning, with no detectable cause, will be enrolled. Participants will take cannabis oil for 30 days. Participants will be asked to complete questionnaires about their pain and wellbeing before they begin the study and at follow-up visits at 4, 12 and 36 weeks after the beginning of the study. Participants will be asked to record the treatment’s unexpected effects in a diary.

What are the possible benefits and risks of participating?
Patients will be given a prescription and will receive the prescribed cannabis oil at the pharmacy to purchase independently. Cannabis oil will have to be used for 1 month, being careful not to drive or do jobs that require constant attention. Patients will be able to contact their doctor for any eventuality. Patients will be regularly followed up to 6 months after the end of therapy.

Where is the study run from?
CIR Dental School (Italy)

When is the study starting and how long is it expected to run for?
From February 2017 to November 2019

Who is funding the study?
This study is investigator-initiated and funded

Who is the main contact?
Prof Paolo Giacomo Arduino
paologiacomo.arduino@unito.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paolo Giacomo Arduino

ORCID ID

https://orcid.org/0000-0002-8798-7834

Contact details

Via Nizza 230
Turin
10100
Italy
+390116331522
paologiacomo.arduino@unito.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Evaluating the feasibility, suitability and potential efficiency of Cannabis Sativa oil on pain and quality of life assessment for patients with burning mouth syndrome: a prospective open-label single-arm pilot study

Acronym

CANBMS

Study hypothesis

The use of a full cannabis plant extract diluted in oil could be useful in reducing reported oral reported pain not related to a specific clinical mucosal alteration

Ethics approval

Approved 07/01/2017, Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino (Corso Bramante, 88/90, 10126 Torino, Italy; +39 0116334732; urp@molinette.piemonte.it), ref: CIR-PO-2017/01

Study design

A prospective open-label single-arm pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

Burning mouth syndrome

Intervention

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 the Oral Medicine Section of the CIR Dental School, Turin, Italy, were selected for the present study.

Subjects with an oral burning sensation, classified as BMS according to the International Headache Society criteria, have been collected. Oil dose prescribed ranged from 10 to 40 drops, as the ideal dosing schedule is currently unknown (no dose-finding studies have yet examined the optimal daily amount of specific molecular concentrations of THC and CBD).

The schedule was prescribed as follows: 5 drops twice daily for 5 days, 10 drops twice daily for 5 days, 15 drops twice daily for 5 days, 20 drops twice daily for 15 days. The treatment was provided for 30 days. Follow-up visits were conducted at 4, 12 and 36 weeks after the beginning of the protocol study. The same expert oral physician performed the baseline conventional intraoral examination and follow up. Participants were provided with a diary to record the treatment’s unexpected effects.

Intervention type

Drug

Phase

Not Applicable

Drug names

The full cannabis plant extract was prepared in specialised pharmacies starting from standardised cannabis plant material (cannabis flos) by means of Romano-Hazekamp or Sifap-Sifo extraction and diluted in oil (1 g of cannabis in 10 g of olive oil).

Primary outcome measure

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

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

Overall trial start date

01/12/2016

Overall trial end date

01/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥ 18
2. Burning mouth syndrome diagnosis
3. No detectable oral mucosal lesions
4. Able to complete the present clinical trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 patients

Total final enrolment

17

Participant 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

Recruitment start date

01/02/2017

Recruitment end date

01/11/2019

Locations

Countries of recruitment

Italy

Trial participating centre

CIR Dental School
Via Nizza 230
Turin
10100
Italy

Sponsor information

Organisation

University of Turin

Sponsor details

Via Nizza 230
Turin
10100
Italy
+390116331522
paologiacomo.arduino@unito.it

Sponsor type

University/education

Website

https://www.dentalschool.unito.it/it

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the primary and secondary endpoints along with any other reportable data will be published in peer-review journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

01/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/06/2020: The total final enrolment was added. 14/04/2020: Trial’s existence confirmed by Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino.