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Clinical Trials/NCT05946473
NCT05946473
Not yet recruiting
Not Applicable

Development of a Novel Anti-caries Chewing Gum

University of Toronto0 sites30 target enrollmentJuly 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Plaque
Sponsor
University of Toronto
Enrollment
30
Primary Endpoint
Change in target species of the oral microbiome
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 2023
End Date
April 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dennis Cvitkovitch

Professor

University of Toronto

Eligibility Criteria

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)
  • Currently using any mouth rinse
  • Pregnant or breastfeeding women

Outcomes

Primary Outcomes

Change in target species of the oral microbiome

Time Frame: 28 days

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

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