The effect of a cannabidiol (medicinal cannabis) toothpaste and mouthwash on gingivitis

Phase 1

• Conditions: Gingivitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000882123
• Lead Sponsor: Cannvalate (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-21
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gum health measured by the Gingivitis Bleeding Index[After 30 days of 3 x daily administration (Day 35)]

Secondary Outcome Measures

Name	Time	Method
Gum health measured by the Gingivitis Bleeding Index[After 5 days of 3 x daily administration (Day 10)];Safety of the investigational product measured by the number and type of adverse events reported by trial participants[After 30 days of 3 x daily administration (Day 35) and throughout trial. ]