The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
NCT ID: NCT05330793
Last Updated: 2023-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2021-10-26
2022-12-16
Brief Summary
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* Determine the safety and effectiveness of oral probiotic intervention with or without a novel toothpaste and compare with placebo
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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: Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)
1 active oral probiotic with placebo toothpaste
Oral probiotic
an oral probiotic intervention with or without a novel ADP1 toothpaste
Placebo
placebo without Oral probiotic or toothpaste
Oral probiotic lozenges + toothpaste with ADP-1
Oral probiotic and ADP1 toothpaste
Oral probiotic
an oral probiotic intervention with or without a novel ADP1 toothpaste
Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)
Placebo without oral probiotics or ADP1 toothpaste
Placebo
placebo without Oral probiotic or toothpaste
Interventions
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Oral probiotic
an oral probiotic intervention with or without a novel ADP1 toothpaste
Placebo
placebo without Oral probiotic or toothpaste
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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Roseman University of Health Sciences
OTHER
USANA Health Sciences
INDUSTRY
Responsible Party
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Locations
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Roseman University of Health Sciences College of Dental Medicine
South Jordan, Utah, United States
Countries
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Other Identifiers
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202001
Identifier Type: -
Identifier Source: org_study_id
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