Not Yet RecruitingPhase 2ACTRN12619000882123

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

A phase 2a randomised controlled trial investigating the effect of CBD (cannabidiol) toothpaste and mouthwash on gingivitis versus placebo in healthy volunteers

Sponsor

Cannvalate (Australia)

Enrollment

40 participants

Start Date

Aug 1, 2019

Study Type

Interventional

Conditions

Gingivitis

Summary

The purpose of this trial is to assess whether combination toothpaste and mouthwash containing cannabidiol (CBD) can improve symptoms of Gingivitis compared to placebo. This is a double-blind, placebo-controlled, between-subject study design comprising of four visits in which gingivitis is assessed using the gum bleeding index (GBI; A screening visit, Baseline (Day 5), Day 10 and Day 35). Healthy participants will visit the dental clinic for initial assessment for suitability of inclusion in the study. If the participant is not excluded he/she will be assessed on the Gingivitis Bleeding Scale (GBI), instructed not to use dental hygiene (brushing teeth or using mouthwash) for 5 days and to return for their next visit (Baseline/Day 5). The participant will then be randomized to the trial and provided with treatment (CBD toothpaste/mouthwash or placebo toothpaste/mouthwash) which they will use for the next 30 days. On Days 10 (after 5 days of treatment) and Day 35 (after 30 days of treatment) they will return for another GBI assessment. The study duration is 35 days (from screening visit to 30-day follow-up visit). Treatment (brushing teeth and using mouthwash) will occur three times a day for 30 days in total.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 30 Yearss

Inclusion Criteria13

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 Criteria13

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

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Interventions

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.