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Development of a Novel Anti-caries Chewing Gum

Primary Purpose

Dental Plaque, Dental Caries, Periodontal Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gum base containing xylitol and essencial oils
Gum base with no additives
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental gum formulation

    Placebo

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    July 6, 2023
    Sponsor
    University of Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05946473
    Brief Title
    Development of a Novel Anti-caries Chewing Gum
    Official Title
    Development of a Novel Anti-caries Chewing Gum
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Plaque, Dental Caries, Periodontal Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental gum formulation
    Arm Type
    Experimental
    Arm Description
    Participants will be asked to chew 2 pieces of chewing gum containing additives 2 times a day for a four-week period
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Gum base containing xylitol and essencial oils
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Gum base with no additives
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in target species of the oral microbiome
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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) Smokers Currently using any mouth rinse Pregnant or breastfeeding women

    12. IPD Sharing Statement

    Learn more about this trial

    Development of a Novel Anti-caries Chewing Gum

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