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| Name | Class |
|---|---|
| Roseman University of Health Sciences | OTHER |
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Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1) | Other | 1 active oral probiotic with placebo toothpaste |
|
| Oral probiotic lozenges + toothpaste with ADP-1 | Active Comparator | Oral probiotic and ADP1 toothpaste |
|
| Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1) | Placebo Comparator | Placebo without oral probiotics or ADP1 toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral probiotic | Dietary Supplement | an oral probiotic intervention with or without a novel ADP1 toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Index | • Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. | 8 weeks |
| Plaque Index | • Plaque index is used as a method of recording the presence of plaque on individual tooth surfaces. These surfaces are mesial, distal, buccal and lingual. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Halitosis | • Halitosis will be measured using a digital bad breath checker. The instrument is a small device with a sensor that sits near your mouth. This instrument senses volatile sulfur compounds or VSCs and produces a parts-per-billion (ppb) measurement of the foul-smelling compounds. | 8 weeks |
| Intraoral Imaging |
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Inclusion Criteria:
Exclusion Criteria:
• Probing depths less than 3mm
Breastfeeding, pregnant or trying to become pregnant
Currently taking or have taken any of the following within 30 days of enrollment:
Frequent alcohol consumption (> 2 drinks per day, or > 8 per week for women, or > 15 per week for men)
Use of marijuana (which can cause dry mouth or other conditions) or recreational drugs
Use of tobacco products including chewing tobacco and all types of cigarettes (e-cigarettes)
Known allergy to any product ingredient (ingredient list provided by USANA)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roseman University of Health Sciences College of Dental Medicine | South Jordan | Utah | 84095 | United States |
YES
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of an oral probiotic intervention with or without a novel toothpaste and compared with placebo toothpaste and placebo lozenges.
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| Placebo | Dietary Supplement | placebo without Oral probiotic or toothpaste |
|
• Intraoral imaging of tooth decay can be measured in at least one of the following methods: (1) Using traditional intraoral imaging camera in the dental clinics to visualize tooth decay on the tooth surface, and (2) Using a laser fluorescence pen to detect tooth decay. |
| 8 weeks |
| SAQ | Self-Assessment Questionnaire will consist of no more than 100 questions examining quality of life across one or several of these domains: (1) social well-being, (2) mental well-being, (3) physical well-being, (4) oral health and (5) dental hygiene and halitosis.dental hygiene and halitosis. | 8 weeks |
| Microbial Community Analysis | Oral swabs from the gum line will be collected using DNA Genotek OMNIgene-ORAL swab kits and stored in the accompanying swab storage tube for microbial community analysis. qPCR testing will be performed in house in USANA. | 8 weeks |
| D019602 |
| Food and Beverages |