Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Salivary factors present in healthy and caries-active subjects during the research study. |
Saliva will be collected from healthy and caries-active subjects during the research study. The differences in salivary factors between the healthy and caries-active groups will be compared. |
Up to 6 months |
|
Primary |
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2 |
Saliva and dental plaque will be collected during the baseline and week 2 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols. |
Changes from baseline to 2 weeks (Screening) |
|
Primary |
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4 |
Saliva and dental plaque will be collected during the week 2 and week 4 study visits. The amount of citrulline and/or ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols. |
Changes from week 2 to week 4 (Baseline) |
|
Primary |
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8 |
Saliva and dental plaque will be collected during the week 4 and week 8 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols. |
Changes from week 4 to week 8 (Washout) |
|
Primary |
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12 |
Saliva and dental plaque will be collected during the week 8 and week 12 visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols |
Changes from week 8 to week 12 (Evaluation) |
|
Primary |
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12. |
Saliva and dental plaque will be collected during the baseline and week 12 study visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols. |
Changes from baseline to week 12 (Evaluation) |
|
Secondary |
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2 |
Saliva and dental plaque will be collected during the baseline and week 2 study visits.Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured. |
Changes from baseline to week 2 |
|
Secondary |
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4 |
Saliva and dental plaque will be collected during the week 2 and week 4 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured. |
Changes from week 2 to week 4 |
|
Secondary |
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8 |
Saliva and dental plaque will be collected during the week 4 to week 8 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured. |
Changes from week 4 to week 8 |
|
Secondary |
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12 |
Saliva and dental plaque will be collected during the week 8 and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured. |
Changes from week 8 to week 12 |
|
Secondary |
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12 |
Saliva and dental plaque will be collected during the baseline and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured. |
Changes from baseline to week 12 |
|