Back to resultsDevelopment 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
About this trial
This is an interventional prevention trial for Dental Plaque
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
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
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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