Oral Health
Conditions
Brief summary
* Randomized double-blind, placebo-controlled trial on the effects of an oral probiotic intervention with or without a novel ADP-1 toothpaste Objective * Determine the safety and effectiveness of oral probiotic intervention with or without a novel toothpaste and compare with placebo
Detailed description
Hypotheses: 1. Subjects using oral probiotics will have better oral health than subjects using placebo toothpaste and placebo lozenges. 2. Subjects using oral probiotics and ADP-1 toothpaste will have better oral health than subjects using oral probiotics and regular toothpaste, and subjects using regular toothpaste and placebo lozenges.
Interventions
DIETARY_SUPPLEMENTOral probiotic
an oral probiotic intervention with or without a novel ADP1 toothpaste
DIETARY_SUPPLEMENTPlacebo
placebo without Oral probiotic or toothpaste
Sponsors
Roseman University of Health Sciences
USANA Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18 to 65 years old * Fluent in English * Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm) * Bleeding on probing on 30%+ areas * Able to perform oral hygiene adequately after formal instructions * Able to understand and comply with study procedure * Able to provide written informed consent * Able to come to Roseman Dental Clinics in South Jordan for a 90-minute pre-screening to determine eligibility * Able to complete five (90-minute) clinic visits in 2-week intervals
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: * Oral probiotics * Antibiotic medications * Antifungal medications (e.g., nystatin, clotrimazole, ketoconazole, griseofulvin) * Antiseptic medications * Immunosuppressant and/or chemotherapeutic medications * Medications that could affect gum response measurement (e.g., calcium channel blockers, cyclosporin, anti-seizures like phenytoin and related drugs, anti-inflammatory agents) * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index | 8 weeks | • 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. |
| Plaque Index | 8 weeks | • 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Halitosis | 8 weeks | • 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. |
| Intraoral Imaging | 8 weeks | • 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. |
| SAQ | 8 weeks | 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. |
| Microbial Community Analysis | 8 weeks | 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. |
Countries
United States
Outcome results
None listed