Dental Caries, Dental Plaque, Periodontal Disease
Conditions
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.
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
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in target species of the oral microbiome | 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 |
Outcome results
None listed