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.

Tooth Decay Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301113
• Other study ID #: IRB#: 01202023_torabiDH_CBDloz
• Status: Completed
• Phase: N/A
• Start date: January 27, 2023
• Est. completion date: February 11, 2023

Study information

• Verified date: March 2024
• Source: West Coast University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 11, 2023
• Est. primary completion date: February 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Dietary Supplement:
• CBD infused candy
300 Nano mg CBD Candy cherry flavor
• Sugar free Candy
Raspberry flavored sugar free candy

Locations

Country	Name	City	State
United States	West Coast University	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
West Coast University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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