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Trial registered on ANZCTR


Registration number
ACTRN12619000882123p
Ethics application status
Not yet submitted
Date submitted
14/06/2019
Date registered
21/06/2019
Date last updated
21/06/2019
Date data sharing statement initially provided
21/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a cannabidiol (medicinal cannabis) toothpaste and mouthwash on gingivitis
Scientific title
A phase 2a randomised controlled trial investigating the effect of CBD (cannabidiol) toothpaste and mouthwash on gingivitis versus placebo in healthy volunteers
Secondary ID [1] 298446 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingivitis 313187 0
Condition category
Condition code
Oral and Gastrointestinal 311648 311648 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over the 30-day administration period, participants will be given either toothpaste/mouthwash containing CBD or toothpaste/mouthwash not containing CBD (placebo) to be used three times daily (morning, noon and evening). Participants will be told to brush their teeth with the supplied toothpaste using a soft bristle toothbrush morning, noon and before bed. Participants should brush for no less than 180 seconds and then rinse with the supplied mouthwash for no less than 120 seconds. Participants will also be asked not to drink water or rinse the mouth with water for 30 minutes following the mouthwash. The toothpaste containing the CBD will be supplied in a 75ml tube containing 125mg of CBD (99% pure), equivalent to 1.667mg/ml; the mouthwash containing the CBD will be supplied in a 500ml bottle containing 125mg CBD (99% pure), equivalent to 0.25mg/ml. Treatments will be provided in appropriate containers for toothpaste and mouthwash. The approximate total volume of toothpaste on the toothbrush, independent of CBD, is expected to be that of a standard serve of toothpaste, equivalent to approximately 2g. This equates to 3.334mg of CBD per serve of toothpaste. The total volume per administration of mouthwash is expected to be a normal sluice, approximately 20ml, equating to 0.5mg of CBD in each serve.
Treatment compliance will be monitored by the use of a participant treatment log or mobile app where participants will record that they have taken the study treatment each day. Participants will also be asked to return their unused study treatment and this will be measured by study staff.
Intervention code [1] 314692 0
Treatment: Drugs
Comparator / control treatment
The placebo toothpaste contains the same ingredients as the active treatment without the CBD. The placebo mouthwash contains the same ingredients as the active treatment without the CBD. Both treatments and the placebo are identical in appearance.
Control group
Placebo

Outcomes
Primary outcome [1] 320353 0
Gum health measured by the Gingivitis Bleeding Index
Timepoint [1] 320353 0
After 30 days of 3 x daily administration (Day 35)
Secondary outcome [1] 371316 0
Gum health measured by the Gingivitis Bleeding Index
Timepoint [1] 371316 0
After 5 days of 3 x daily administration (Day 10)
Secondary outcome [2] 371802 0
Safety of the investigational product measured by the number and type of adverse events reported by trial participants
Timepoint [2] 371802 0
After 30 days of 3 x daily administration (Day 35) and throughout trial.

Eligibility
Key inclusion criteria
• Aged between 18 and 30 years (inclusively)
• Have current score of less than 1 on the gum bleeding index (GBI) at clinical evaluation (V0) and a score of more than 1 at randomization (V1) visit.
• No history of gum disease
• No known allergic reaction to cannabis products with previous use
• Ability to speak and read English
• Have no pre-existing physical or neurological conditions, no previous or current history of severe psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
• Not currently pregnant or lactating
• Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
• Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
• Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
• Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
• in good general health, without orthodontic appliances
• a minimum of 16 natural teeth with facial and lingual scorable surfaces for consideration. Teeth with scorable surfaces exclude third molars, teeth (or implants) with crowns or bridge and teeth with large restorations covering >50% of the tooth
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects presenting with any of the following will not be included in the trial:
• Aged under 18 years or over 30 years.
• A score greater than “0” on the GBI at V0 (inclusion evaluation)
• Current gum disease
• Previous gum disease
• Inability to speak or read English
• History of drug or substance abuse or current illicit drug abuse
• History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
• Currently pregnant or breastfeeding
• Currently taking medications
• Have no previous experience with cannabinoids or currently taking cannabinoids
• Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit
• Current smoker

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by sealed opaque envelopes, which are to be kept in a locked filing cabinet in the Principal Investigator's office and will only be opened in the case of an emergency. In addition, the full randomisation list will be kept in a password protected document in a restricted access confidential folder on a secure server. Only the person who is responsible for generating the randomisation list (a disinterested third party) will have the password to access this document.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation for this trial will be conducted using computerised sequence generation. There will be no stratification for this trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical tests will be performed two tailed at the 5% significance level and performed using IBM SPSS statistical package. Z scores for the distribution will be calculated for each variable and displayed in histogram form. Out of range values will be recoded as missing values.
Results for the changes in GBI will be assessed using repeated measures ANOVA in which 3 time points will be assessed (V1-V3) by two groups. We will use planned comparisons to examine differences between the effects of the CBD and placebo treatments at different timepoints to examine the outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
6/12/2019
Actual
Date of last data collection
Anticipated
10/01/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302992 0
Commercial sector/Industry
Name [1] 302992 0
Cannvalate (Australia)
Country [1] 302992 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cannvalate (Australia)
Address
C2 Level 1/459 Toorak Rd,
Toorak VIC 3142
Country
Australia
Secondary sponsor category [1] 302954 0
None
Name [1] 302954 0
Address [1] 302954 0
Country [1] 302954 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303542 0
Bellberry HREC
Ethics committee address [1] 303542 0
Ethics committee country [1] 303542 0
Australia
Date submitted for ethics approval [1] 303542 0
17/07/2019
Approval date [1] 303542 0
Ethics approval number [1] 303542 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94026 0
Prof Con Stough
Address 94026 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 94026 0
Australia
Phone 94026 0
+61 3 9214 8167
Fax 94026 0
Email 94026 0
cstough@gmail.com
Contact person for public queries
Name 94027 0
Sarah Catchlove
Address 94027 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 94027 0
Australia
Phone 94027 0
+61 3 9214 8930
Fax 94027 0
Email 94027 0
scatchlove@swin.edu.au
Contact person for scientific queries
Name 94028 0
Con Stough
Address 94028 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 94028 0
Australia
Phone 94028 0
+61 3 9214 8167
Fax 94028 0
Email 94028 0
cstough@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results of this trial will be disseminated via peer-reviewed publications and at academic conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identified raw data will be uploaded to an appropriate repository. Otherwise, as the Intellectual Property of this study are owned by the sponsor and may be used for the purposes of commercialisation of the study product, the trial data will not be made available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.