Clinical trial NCT06301113: This Research Study Examines the Effects of Cannabidiol-infused Candy on Reducing the Bacteria Causing Tooth Decay, When Comparing it to a Sugar Free Candy on Adults.
Official title: The Antimicrobial Impact of CBD-infused Lozenges on Streptococcus Mutans When Compared to Sugar Free Candy, on Thirty Adults Who Meet the Inclusion Criteria, Randomly Placed Into Two Groups Utilizing Quantitative Polymerized Chain Reaction Bacterial Analysis Technique.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Decay
Keywords: CBD, streptococcus mutans
Lead sponsor: West Coast University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 Participants were randomly assigned to groups A (experimental group)and B (Control group).
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to compare the effect of CBD candy versus sugar free candy on reducing the number of bacteria causing tooth decay, in adults The main question is to see whether CBD have any effect on reducing the number of Streptococcus mutans, in the oral cavity the main bacteria causing tooth decay.

Participants will be randomly placed in a group, and assigned to take either CBD-infused lozenge (if in the experimental group) or a sugar-free candy (if in the control group) once a day for 15 days.

A sample of saliva will be collected and analyzed in a lab before and after consumption of the candy to see whether either product could reduce the harmful bacteria in the mouth.


Eligibility criteria: Inclusion Criteria:

Adults aged 18 years or older, that were not taking any antibiotics, using prescribed toothpaste or mouthwash, who were not experiencing any tooth ache or mouth sores, have not visited the dentist within the past 48 hours, who willingly signed a consent form agreed to participate and be available on specific dates set by investigators and followed the recommended regimen for 15 days were included in the study. The suggested regimen involved consuming one candy in the evening at approximately the same time, allowing it to dissolve in the mouth without crushing it. Furthermore, individuals who could abstain from alcohol consumption for at least 12 hours before saliva collection on day 1 and day 15 and refrain from food or drink (except water) for preferably 2 hours were also eligible to participate in this clinical trial.

Exclusion Criteria:

Encompassed individuals taking or recently completing an antibiotic regimen within two weeks before participation. Participants with allergies to specific substances, such as propriety broad spectrum nano hemp extract, isomalt, organic stevia, natural or artificial cherry flavoring, natural coloring, maltitol syrup, or citric acid, were also excluded. Further exclusion criteria included participants using professional-strength anti-cavity or anti-gingivitis products, individuals experiencing toothache or mouth sores, and those who had visited a dentist within the last 48 hours. In addition, participants who did not meet the saliva collection guideline protocols were excluded from the study.

Primary outcomes:
measure: To investigate the impact of CBD-infused lozenges on Streptococcus mutans, by employing quantitative polymerase chain reaction (qPCR) for bacterial analysis.
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: West Coast University
state: California
Study officials:
References: