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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Coast University

Anaheim, California, 92802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBD infused candy

Dietary Supplement

300 Nano mg CBD Candy cherry flavor

Sugar free Candy

Dietary Supplement

Raspberry flavored sugar free candy

Primary outcomes

  1. To investigate the impact of CBD-infused lozenges on Streptococcus mutans, by employing quantitative polymerase chain reaction (qPCR) for bacterial analysis.

    Time frame: 15 days

    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.

Sponsors and collaborators

Lead sponsor

West Coast University

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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