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.
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.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2023
CompletedFirst Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedMarch 8, 2024
March 1, 2024
15 days
March 1, 2024
March 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate the impact of CBD-infused lozenges on Streptococcus mutans, by employing quantitative polymerase chain reaction (qPCR) for bacterial analysis.
Align with the purpose of this clinical trial was to investigate the effect of CBD-infused lozenges on S. mutant, this clinical trial considered the dependent variable to be S. mutans gene expression as well as the 16S rRNA sequence, which is the universal gene in all bacteria measured in a continuous qPCR amplification cycle. The changes in the relative abundance of S. mutans pre and post-CBD lozenge consumption for 15 days were compared with the sugar-free candy and were measured via qPCR laboratory analysis.
15 days
Study Arms (2)
300 Nano mg CBD Candy
EXPERIMENTALSugar free raspberry flavor candy
PLACEBO COMPARATORInterventions
Raspberry flavored sugar free candy
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Coast University
Anaheim, California, 92802, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 8, 2024
Study Start
January 27, 2023
Primary Completion
February 11, 2023
Study Completion
February 11, 2023
Last Updated
March 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share