The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste

Study Overview
=================
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: Subjects using oral probiotics will have better oral health than subjects using placebo toothpaste and placebo lozenges. 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.

Official Title
-----------------
Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste

Conditions
-----------------
Oral Health

Intervention / Treatment
-----------------
* Dietary Supplement: Oral probiotic
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)<br>1 active oral probiotic with placebo toothpaste | Dietary Supplement: Oral probiotic<br>* an oral probiotic intervention with or without a novel ADP1 toothpaste<br>* Other names: ADP1 toothpaste;Dietary Supplement: Placebo<br>* placebo without Oral probiotic or toothpaste<br>|
| Active Comparator: Oral probiotic lozenges + toothpaste with ADP-1<br>Oral probiotic and ADP1 toothpaste | Dietary Supplement: Oral probiotic<br>* an oral probiotic intervention with or without a novel ADP1 toothpaste<br>* Other names: ADP1 toothpaste;|
| Placebo Comparator: Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)<br>Placebo without oral probiotics or ADP1 toothpaste | Dietary Supplement: Placebo<br>* placebo without Oral probiotic or toothpaste<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | • 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 |