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NCT05946473 Clinical Trial

Development of a Novel Anti-caries Chewing Gum

Dental Caries Clinical Trial

Official title:
Development of a Novel Anti-caries Chewing Gum

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05946473
Other study ID # 44196
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2023
Est. completion date April 2024

Study information
Verified date July 2023
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study is designed to evaluate the chewing gum's ability to modulate the oral microbiome in human participants, in addition to its safety.

Description:

The goal of this project is to develop a pre-biotic chewing gum that is designed to promote a healthy oral microbiome. The gum will contain compounds that will: a) be unable to be converted to acids; b) target the cariogenic S. mutans population; c) promote the stability of a healthy environment by modulating plaque pH via base-generating compounds; d) promote tooth remineralization by increasing saliva flow and by addition of calcium phosphate.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date April 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - In good general health, no relevant medical history - No dental treatment in the previous 3 months - Willing to participate and give written informed consent Exclusion Criteria: - Patients undergoing fixed or removable orthodontic treatment - Patients using removable prosthesis - History of head and neck radiation therapy - History of adverse reaction or allergies to xylitol or other additives - Antibiotics use in the last four weeks - Patients with any systemic diseases - Xerostomia (also medication-induced) - Smokers - Currently using any mouth rinse - Pregnant or breastfeeding women

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Gum base containing xylitol and essencial oils
Participants will be asked to chew 2 pieces of chewing gum containing additives for 10 minutes after eating in the morning, and after one meal in the evening, for a four-week period
• Gum base with no additives
Participants will be asked to chew 2 pieces of pure gum base for 10 minutes after eating in the morning, and after one meal in the evening, for a four-week period

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Toronto

Outcome
Type Measure Description Time frame Safety issue
Primary Change in target species of the oral microbiome Total microbiome analyses will be performed at the beginning and end of the study (4 weeks) to assess total cultivable flora, levels of S. mutans, S. salivarius, and P. gingivalis in addition to using qRT-PCR from plaque and saliva samples 28 days
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