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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Caries
• Dental Plaque
• Periodontal Disease
• Periodontal Diseases

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