ACTRN12619000882123
Not yet recruiting
Phase 1
A phase 2a randomised controlled trial investigating the effect of CBD (cannabidiol) toothpaste and mouthwash on gingivitis versus placebo in healthy volunteers
Cannvalate (Australia)0 sites40 target enrollmentJune 21, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cannvalate (Australia)
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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