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Not yet recruitingNCT05946473Updated Jul 14, 2023

Development of a Novel Anti-caries Chewing Gum

An interventional study of Gum base containing xylitol and essencial oils and Gum base with no additives in Dental Plaque, Dental Caries and Periodontal Disease, sponsored by University of Toronto. Not yet recruiting. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-14.

Sponsored by University of Toronto · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Plaque
  • Dental Caries
  • Periodontal Disease
03

In context

Dental Caries

1,110 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 917 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental gum formulation

    Participants will be asked to chew 2 pieces of chewing gum containing additives 2 times a day for a four-week period

    Dietary Supplement: Gum base containing xylitol and essencial oils

  • Placebo comparator
    Placebo

    Participants will be asked to chew 2 pieces of pure gum base with no additives chewing gum 2 times a day for the same four-week period.

    Dietary Supplement: Gum base with no additives

Interventions

  • Dietary supplementGum 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

  • Dietary supplementGum 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05946473
Lead sponsor
University of Toronto
Responsible party
Dennis Cvitkovitch (Professor, University of Toronto) — Principal investigator
First posted
Jul 14, 2023
Start date
Jul 2023 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Apr 2024 (estimated)
Last update
Jul 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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