Development of a Novel Anti-caries Chewing Gum

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of a Novel Anti-caries Chewing Gum

Conditions
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Dental Plaque, Dental Caries, Periodontal Disease

Intervention / Treatment
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* Dietary Supplement: Gum base containing xylitol and essencial oils
* Dietary Supplement: Gum base with no additives


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental gum formulation<br>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<br>* 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<br>|
| Placebo Comparator: Placebo<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days |