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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gum base containing xylitol and essencial oils | Dietary 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D003731 | Dental Caries |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
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| Gum base with no additives | Dietary 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 |
|
| D009059 |
| Mouth Diseases |