Dental PlaqueNCT05946473
Development of a Novel Anti-caries Chewing Gum
A study testing Gum base containing xylitol and essencial oils and Gum base with no additives in people with Dental Plaque and Dental Caries, run by University of Toronto.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Dental Caries, Periodontal Disease
- What is being tested?
- Gum base containing xylitol and essencial oils and Gum base with no additives
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health, no relevant medical history
- No dental treatment in the previous 3 months
- Willing to participate and give written informed consent
Who cannot join
- 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
Show all 10Show fewer
- Xerostomia (also medication-induced)
- Smokers
- Currently using any mouth rinse
- Pregnant or breastfeeding women
About this study
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.
- Conditions
- Dental Plaque, Dental Caries, Periodontal Disease
- Being tested
- Gum base containing xylitol and essencial oils, Gum base with no additives
- Medical subject headings
- Dental Plaque, Dental Caries, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum base containing xylitol and essencial oilsDietary supplement
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 additivesDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental gum formulation | Experimental | Participants will be asked to chew 2 pieces of chewing gum containing additives 2 times a day for a four-week period Receives: Dietary Supplement: Gum base containing xylitol and essencial oils |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Gum base with no additives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Cvitkovitch, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946473
- Sponsor's protocol ID
- 44196
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Anti-caries Chewing Gum
- ClinicalTrials.gov ID
- NCT05946473
- Acronym / sponsor ID
- 44196
- Conditions
- Dental Plaque, Dental Caries, Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental gum formulation | Experimental | Dietary Supplement: Gum base containing xylitol and essencial oilsParticipants will be asked to chew 2 pieces of chewing gum containing additives 2 times a day for a four-week period |
| Placebo | Placebo comparator | Dietary Supplement: Gum base with no additivesParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- In good general health, no relevant medical history
- No dental treatment in the previous 3 months
- Willing to participate and give written informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum base containing xylitol and essencial oilsParticipants 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 supplement | Experimental gum formulation |
| Gum base with no additivesParticipants 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 | Dietary supplement | Placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gum base containing xylitol and essencial oils and Gum base with no additives in people with Dental Plaque and Dental Caries, run by University of Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in target species of the oral microbiome (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.